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GUIDANCE DOCUMENT

Reviewer Guidance for Automatic X-Ray Film Processor 510(k) February 1990

Final

Reviewer Guidance for Automatic X-Ray Film Processor 510(k)

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This document addresses issues in premarket notifications for Medical Film Automatic Processors.


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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

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