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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K253956
Device Name ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
Applicant
Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Applicant Contact Anne Bertron
Correspondent
Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Correspondent Contact Ng Wing
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/10/2025
Decision Date 05/21/2026
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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