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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K242237
Device Name Jewel Soft Tissue Reinforcement Device (102-6005)
Applicant
Xiros Limited
Springfield House
Whitehouse Lane
Yeadon,  GB LS19 7UE
Applicant Contact Grannells Janet
Correspondent
Xiros Limited
Springfield House
Whitehouse Lane
Yeadon,  GB LS19 7UE
Correspondent Contact Corey Robinson
Date Received07/30/2024
Decision Date 07/15/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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