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510(k) K162934

Biodesign Parastomal Hernia Repair Graft by Cook Biotech Incorporated — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2017
Date Received
October 20, 2016
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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