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FDA 510(k) Application Details - K080317
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
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510(K) Number
K080317
Device Name
Colonoscope And Accessories, Flexible/Rigid
Applicant
SYNTHEON LLC
7290 SW 42ND ST.
MIAMI, FL 33155 US
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Contact
AL WEISENBORN
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FDF
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More FDA Info for this Product Code
Date Received
02/06/2008
Decision Date
04/29/2008
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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