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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 K120373
Device Name INSORB ABSORBALBE STAPLE
Applicant
Incisive Surgical, Inc.
14405 21st Ave. N.
Suite 130
Plymouth,  MN  55447
Applicant Contact DAVID HERRIDGE
Correspondent
Incisive Surgical, Inc.
14405 21st Ave. N.
Suite 130
Plymouth,  MN  55447
Correspondent Contact DAVID HERRIDGE
Regulation Number878.4750
Classification Product Code
GDW  
Date Received02/06/2012
Decision Date 03/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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