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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 K220091
Device Name Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Applicant
Xiros, Ltd.
Springfield House Lane, Whitehouse Lane
Leeds,  GB LS17 7UE
Applicant Contact Steve Curran
Correspondent
Xiros, Ltd.
Springfield House Lane, Whitehouse Lane
Leeds,  GB LS17 7UE
Correspondent Contact Steve Curran
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OWX  
Date Received01/12/2022
Decision Date 08/26/2022
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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