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Guidance Documents/Guidance-Document/Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities

Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

August 1, 1993

March 17, 2020

Center for Devices and Radiological Health

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