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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 K223218
Device Name Parietene Macroporous Mesh
Applicant
Sofradim Production
116 Ave. Du Formans
Trévoux,  FR 01600
Applicant Contact Jhony Mallet
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Wing Ng
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/17/2022
Decision Date 12/02/2022
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
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