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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 K141053
FOIA Releasable 510(k) K141053
Device Name OVINE TISSUE MATRIX(OTM)
Applicant
TELA BIO, INC.
1 GREAT VALLEY PARKWAY, SUITE 24
MALVEN,  PA  19355
Applicant Contact DONNA STAUFFER
Correspondent
TELA BIO, INC.
1 GREAT VALLEY PARKWAY, SUITE 24
MALVEN,  PA  19355
Correspondent Contact DONNA STAUFFER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/24/2014
Decision Date 12/11/2014
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
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