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GUIDANCE DOCUMENT

Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer Guidance for Industry and for FDA Reviewers January 2000

Download the Final Guidance Document
Final
Docket Number:
FDA-1999-D-4090
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The purpose of this document is to facilitate the preparation and the review of premarket submissions for nitric oxide delivery apparatus, nitric oxide analyzers, and nitrogen dioxide analyzers.

 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1999-D-4090.

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