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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K934256
Device Name GLOBAL MEDICAL CUTTING BIOPSY NEEDLE
Applicant
Global Medical Prods, Inc.
Wickhams Cay 1
P.O. Box 362
Road Town, Tortola,  VG
Applicant Contact PETER CLARK
Correspondent
Global Medical Prods, Inc.
Wickhams Cay 1
P.O. Box 362
Road Town, Tortola,  VG
Correspondent Contact PETER CLARK
Regulation Number876.1075
Classification Product Code
FCG  
Date Received08/31/1993
Decision Date 03/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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