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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Needle, Surgical
510(k) Number K950311
Device Name GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE
Applicant
GLOBAL MEDICAL PRODUCTS, LTD.
244 MAIN ST., SOUTH
P.O. BOX 505
WOODBURY,  CT  06798 -0505
Applicant Contact PETER CLARK
Correspondent
GLOBAL MEDICAL PRODUCTS, LTD.
244 MAIN ST., SOUTH
P.O. BOX 505
WOODBURY,  CT  06798 -0505
Correspondent Contact PETER CLARK
Regulation Number878.4800
Classification Product Code
GDF  
Date Received01/16/1995
Decision Date 05/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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