FDA 510(k) Application Details - K951448

Device Classification Name Trocar

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510(K) Number K951448
Device Name Trocar
Applicant GLOBAL MEDICAL PRODUCTS, LTD.
OMAR HODGE BUILDING
WICKHAMS CAY 1, P.O. BOX 362
ROAD TOWN, TORTOLA VG
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Contact PETER CLARK
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Regulation Number 870.1390

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Classification Product Code DRC
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Date Received 03/29/1995
Decision Date 03/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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