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FDA 510(k) Application Details - K994090
Device Classification Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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510(K) Number
K994090
Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant
KARL STORZ IMAGING, INC.
175 CREMONA DR.
GOLETA, CA 93117 US
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Contact
TERRY FERNANDEZ
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Regulation Number
876.1500
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Classification Product Code
FET
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Date Received
12/03/1999
Decision Date
02/04/2000
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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