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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 K141394
Device Name X-REPAIR
Applicant
Synthasome
3030 Bunker Hill St., Suite 308
San Diego,  CA  92109
Applicant Contact ANTHONY RATCLIFFE
Correspondent
Synthasome
3030 Bunker Hill St., Suite 308
San Diego,  CA  92109
Correspondent Contact ANTHONY RATCLIFFE
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OWW  
Date Received05/28/2014
Decision Date 08/06/2014
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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