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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 K241126
Device Name OviTex PRS
Applicant
Tela Bio, Inc.
1 Great Valley Pkwy.
Suite 24
Malvern,  PA  19355
Applicant Contact John Urtz
Correspondent
Tela Bio, Inc.
1 Great Valley Pkwy.
Suite 24
Malvern,  PA  19355
Correspondent Contact John Urtz
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
FTL  
Date Received04/23/2024
Decision Date 05/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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