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FDA 510(k) Application Details - K193235
Device Classification Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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510(K) Number
K193235
Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant
Karl Storz Endoscopy America, Inc.
2151 E. Grand Ave
El Segundo, CA 90245 US
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Contact
Winkie Wong
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Regulation Number
876.1500
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Classification Product Code
FET
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More FDA Info for this Product Code
Date Received
11/25/2019
Decision Date
12/20/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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