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FDA 510(k) Application Details - K063654
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
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510(K) Number
K063654
Device Name
Colonoscope And Accessories, Flexible/Rigid
Applicant
KMS MEDICAL LLC
7290 SW 42ND STREET
MIAMI, FL 33155 US
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Contact
MARIO ARBESU
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
12/08/2006
Decision Date
01/31/2007
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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