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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 K230671
Device Name Pitch PaSoft Tissue Reinforcement Device
Xiros Ltd
Springfield House Lane, Whitehouse Lane
Leeds,  GB LS17 7UE
Applicant Contact Steve Curran
Xiros Inc
20 Cabot Blvd., Suite 300
Mansfield,  MA  02448
Correspondent Contact John Mahoney
Regulation Number878.3300
Classification Product Code
Subsequent Product Code
Date Received03/10/2023
Decision Date 05/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No