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FDA 510(k) Application Details - K200617
Device Classification Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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510(K) Number
K200617
Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, IL 60061 US
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Contact
Michael Loiterman
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Regulation Number
876.1500
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Classification Product Code
FET
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Date Received
03/09/2020
Decision Date
06/23/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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