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FDA 510(k) Application Details - K012198
Device Classification Name
Trocar, Gastro-Urology
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510(K) Number
K012198
Device Name
Trocar, Gastro-Urology
Applicant
GIBBONS SURGICAL CORP.
1112 JENSEN DRIVE, STE.101
VIRGINIA BEACH, VA 23451 US
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Contact
LISA CRISSON
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Regulation Number
876.5090
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Classification Product Code
FBQ
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More FDA Info for this Product Code
Date Received
07/13/2001
Decision Date
08/09/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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