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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

Final
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.

 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.