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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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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