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FDA 510(k) Application Details - K980804
Device Classification Name
Trocar, Gastro-Urology
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510(K) Number
K980804
Device Name
Trocar, Gastro-Urology
Applicant
ENDOSCOPIC CONCEPTS, INC.
50 BREWSTER ST.
PAWTUCKET, RI 02860 US
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Contact
PAMELA PAPINEAU
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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
03/02/1998
Decision Date
04/01/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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