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FDA 510(k) Application Details - K012660
Device Classification Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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510(K) Number
K012660
Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant
GIMMI GMBH
AMSTEL 320-I
AMSTERDAM 1017AP NL
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Contact
DAGMAR MASER
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Regulation Number
876.1500
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Classification Product Code
FET
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Date Received
08/13/2001
Decision Date
12/20/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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