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510(k) K182493

Bovine Pericardial Tissue Patch by Tisgenx — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2019
Date Received
September 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

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