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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
510(k) Number K183472
Device Name DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
Applicant
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact Fredy Varela
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact Fredy Varela
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
GAQ  
Date Received12/14/2018
Decision Date 03/13/2019
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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