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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 K132669
Device Name PROXIFAST ABSORBABLE STAPLE
Applicant
Surgimatix, Inc.
1539 Jarvis Ave.
Elk Grove Village,  IL  60007
Applicant Contact GRACE CARLSON, MD
Correspondent
Surgimatix, Inc.
1539 Jarvis Ave.
Elk Grove Village,  IL  60007
Correspondent Contact GRACE CARLSON, MD
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/27/2013
Decision Date 01/13/2014
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
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