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510(k) K150668

Biodesign Enterocutaneous Fistula Plug by Cook Biotech Incorprated — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2015
Date Received
March 16, 2015
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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