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510(k) K172395

Duatene bilayer mesh by Sofradim Production — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2018
Date Received
August 8, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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