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GUIDANCE DOCUMENT

Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II February 1989

Final

Docket Number:: FDA-2020-D-0957
Issued by:: Guidance Issuing Office

Center for Devices and Radiological Health

This guide provides information about device specifications, criteria, and labeling.

Submit Comments

Submit Comments Online

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

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 written comments should be identified with this document's docket number: FDA-2020-D-0957.

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