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Determination of Intended Use for 510(k) Devices; Guidance - FDA
Determination of Intended Use for 510(k) Devices; Guidance for. CDRH Staff ( Update to K98-1). Document issued on: December 3, 2002. This document ...
ucm082166.pdf

Guidance for Industry - FDA
Page 1. Guidance for Industry on. General/Specific Intended Use. Introduction. This guidance1 document identifies the general principles that will be considered  ...
ucm073945.pdf

Intended Use - Hogan Lovells
Jan 19, 2017 ... FDA Clarifies “Intended Use” Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly. Can Be One Element in Establishing the ...
fda_client_alert_intended_use.pdf?la=en

Intended use as medical device - Memmert GmbH
Intended use as medical device. Classification according to. MDD. Option A6. SNplus, SFplus. The appliance is intended for sterilizing medical material through ...
intended-use-pdf

FDA INTENDED USE
In order for us, here at GHY USA, to enter the appropriate end use code, ... Please refer to the below intended use descriptions required, to ensure your own.
ACE_FDA_INTENDED_USE_GHY.pdf

Clearing Your Indications for Use Staying Under the Umbrella of
use that fall under the umbrella of the intended use for your chosen predicate device, ... indications, a device with a general intended use statement is seemingly ...
clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use-.pdf

Intended Use Codes
Jun 30, 2009 ... Exhibit 27 – 1. FCIC-Appendix III. Type 27 – Intended Use Codes. Edit Description. Intended Use Codes. Code Intended Use FSA-578 Printout.
REC27EXH.PDF

OWNER'S STATEMENT OF INTENDED USE - Houston - City of
HAZMAT/High Piled Inspection Team. 1002 Washington Avenue, Houston, TX 77002. OWNER'S STATEMENT OF INTENDED USE. BUILDING ADDRESS: ...
owners_statement_intended_use.pdf

Proposed Rules
Sep 25, 2015 ... amend its existing intended use regulations for drugs and devices by inserting in §§ 201.128 and 801.4 a reference to the proposed rule to ...
Intended-Use-Proposed-Rule.pdf

Instructions for completing the Affidavit of Intended Use
Instructions for completing the Affidavit of Intended Use. 1. The affidavit must be completed and signed by a member of your firm who has the authority to certify ...
paemp.pdf

MC 371- Acknowledgement and Intended Use of Clear Kerosene
Intended Use of Clear Kerosene. NRS 366.190 and NAC 366.155. This statement serves as an agreement between the purchaser and retailer or supplier.
mc371.pdf

1 INTENDED USE / INDICATIONS FOR USE 2 SUMMARY OF THE
1 INTENDED USE / INDICATIONS FOR USE. The Prosigna® Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which is performed ...
LBL_C02223_06_Package-Insert-Prosigna-Assay-US.pdf

Child Foster Care Statement of Intended Use
Instructions for completing the Child Foster Care Statement of Intended Use. The child foster care rule requires that the license-holder must work with the ...
dhs16_143444.pdf

Intended Use Plan and Pre-Expenditure Report - State of Michigan
Enclosed is the Social Services Block Grant Intended Use Plan and pre- expenditure report for the. State of Michigan. The report covers Federal Fiscal Year 2016 ...
DHS-SSBG-FY16_495684_7.pdf

Water Pollution Control Loan Program 2017 Intended Use Plan The
The Water Pollution Control Loan Program (WPCLP) 2017 Intended Use ... direction regarding the intended uses of the State Revolving Fund (SRF) and the  ...
ifas-2017-intended-use-plan.pdf

FY2017 Intended Use Plan - WV Department of Environmental
Jun 3, 2016 ... This document is the Clean Water State Revolving Fund's Intended Use Plan for state ... Intended Use Plan – Sources and Uses of Funds*.
FY2017CleanWaterSRFIntendedUsePlan.pdf

Intended Use Plan - State Water Resources Control Board - State of
May 16, 2016 ... Intended Use Plan and The Water Quality, Supply, and. Infrastructure Improvement Act of 2014. (Proposition 1 – Chapter 5, Section 79723).
final_2016_cwsrf_iup_report_with_cover.pdf

DR2489 Requestor Release and Affidavit of Intended Use
Driver Record Requestor Release and Affidavit of Intended Use. Records and/or other requests are available at 1881 Pierce St., Lakewood, CO.
DR2489.pdf

INTENDED USE SUMMARY AND EXPLANATION CLIA Complexity
Not to be used for performing assay. Refer to most current package insert accompanying your test kit. INTENDED USE. The QuickVue iFOB ( immunochemical ...
pi_qv_ifobt_20201.pdf

Goods benefiting from customs facilities depending on the intended
Act - customs facilities for goods depending on the intended use - will be dispensed ... Goods, which due to their usage, are brought into the customs territory at a ...
pdf_linker.php?doc=Tares_Zollerleichterungen&lang=en