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FDA 510(k) Application Details - K993544
Device Classification Name
Retractor, Self-Retaining
More FDA Info for this Device
510(K) Number
K993544
Device Name
Retractor, Self-Retaining
Applicant
ADVANCED SURGICAL CONCEPTS (ASC)
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
MARY MCNAMARA CULLINANE
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Regulation Number
876.4730
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Classification Product Code
FFO
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More FDA Info for this Product Code
Date Received
10/19/1999
Decision Date
12/22/1999
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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