FDA 510(k), K141053, OVINE TISSUE MATRIX(OTM)
FDA 510(k), K141053, OVINE TISSUE MATRIX(OTM)
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510(K) Number: K141053
Device Name: OVINE TISSUE MATRIX(OTM)
Manufacturer: TELA BIO, INC.
Device Classification Name: mesh, surgical
Regulation Number: 878.3300
Classification Product Code: FTM
Date Received: 04/24/2014
Decision Date: 12/11/2014
Regulation Medical Specialty: General & Plastic Surgery
Device Name: OVINE TISSUE MATRIX(OTM)
Manufacturer: TELA BIO, INC.
Device Classification Name: mesh, surgical
Regulation Number: 878.3300
Classification Product Code: FTM
Date Received: 04/24/2014
Decision Date: 12/11/2014
Regulation Medical Specialty: General & Plastic Surgery