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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 K201934
Device Name Surgimatix Absorbable Fixation System
Applicant
Surgimatix, Inc.
1539 Jarvis Ave.
Elk Grove Village,  IL  60007
Applicant Contact Dorene Markwiese
Correspondent
Surgimatix, Inc.
1539 Jarvis Ave.
Elk Grove Village,  IL  60007
Correspondent Contact Dorene Markwiese
Regulation Number878.4750
Classification Product Code
GDW  
Date Received07/13/2020
Decision Date 10/01/2021
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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