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510(k) K161204

ENDOCAM Flex HD Camera System 5521 by Richard Wolf Medical Instruments Corporation — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2017
Date Received
April 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

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