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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K951448
Device Name GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE
Applicant
Global Medical Products, Ltd.
Omar Hodge Bldg.
Wickhams Cay 1, P.O. Box 362
Road Town, Tortola,  VG
Applicant Contact PETER CLARK
Correspondent
Global Medical Products, Ltd.
Omar Hodge Bldg.
Wickhams Cay 1, P.O. Box 362
Road Town, Tortola,  VG
Correspondent Contact PETER CLARK
Regulation Number870.1390
Classification Product Code
DRC  
Date Received03/29/1995
Decision Date 03/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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