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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 K152206
Device Name SurgiPure XD Reconstructive Tissue Matrix
Applicant
Tissue Regenix Group Plc
The Biocentre, Innovation Way, Heslington
York,  GB YO20 5NY
Applicant Contact MIKE IZON
Correspondent
Tissue Regenix Group Plc
The Biocentre, Innovation Way, Heslington
York,  GB YO20 5NY
Correspondent Contact MIKE IZON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received08/06/2015
Decision Date 03/08/2016
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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