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510(k) K170763

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend by Acell, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2017
Date Received
March 13, 2017
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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