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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, Absorbable, Orthopaedics, Reinforcement Of Tendon
510(k) Number K230316
Device Name FlexBand; FlexPatch; FlexBand Plus
Applicant
International Life Sciences
2150 Northwest Pkwy. SE Suite G
Marietta,  GA  30076
Applicant Contact Tiffini Wittwer
Correspondent
International Life Sciences
2150 Northwest Pkwy. SE Suite G
Marietta,  GA  30076
Correspondent Contact Tiffini Wittwer
Regulation Number878.3300
Classification Product Code
OWW  
Subsequent Product Code
FTL  
Date Received02/06/2023
Decision Date 05/26/2023
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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