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510(k) K121360

BIODESIGN ENT REPAIR GRAFT by Cook Biotech Incorprated — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2013
Date Received
May 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

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