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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 K951421
Device Name GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES
Applicant
GLOBAL MEDICAL PRODUCTS, LTD.
2230 NURSERY RD.
UNIT D41
CLEARWATER,  FL  34624
Applicant Contact DONALD RYAN
Correspondent
GLOBAL MEDICAL PRODUCTS, LTD.
2230 NURSERY RD.
UNIT D41
CLEARWATER,  FL  34624
Correspondent Contact DONALD RYAN
Regulation Number876.1075
Classification Product Code
FCG  
Date Received03/28/1995
Decision Date 11/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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