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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 K024117
Device Name INSORB ABSORBABLE STAPLES, MODEL SP-B20
Applicant
Incisive Surgical, Inc.
1409 Fairfield Rd.
Minnetonka,  MN  55305
Applicant Contact JIM PETERSON
Correspondent
Incisive Surgical, Inc.
1409 Fairfield Rd.
Minnetonka,  MN  55305
Correspondent Contact JIM PETERSON
Regulation Number878.4750
Classification Product Code
GDW  
Date Received12/13/2002
Decision Date 04/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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