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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 K911252
Device Name PRECISE BARND PI DISPOSABLE SURGICAL STAPLES
Applicant
3M Medical Products Group
3m Center, Bldg. 275-3e-08
St Paul,  MN  55144
Applicant Contact CARL M STORY
Correspondent
3M Medical Products Group
3m Center, Bldg. 275-3e-08
St Paul,  MN  55144
Correspondent Contact CARL M STORY
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/21/1991
Decision Date 07/25/1991
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
Predetermined Change
Control Plan Authorized		 No
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