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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K921051
Device Name 3M PRECISE BRAND INTERNAL SURGICAL STAPLES
Applicant
3M HEALTH CARE, LTD.
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL,  MN  55133
Applicant Contact WILLARD D LARSON
Correspondent
3M HEALTH CARE, LTD.
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL,  MN  55133
Correspondent Contact WILLARD D LARSON
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/05/1992
Decision Date 07/16/1992
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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