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510(k) K170016

Biodesign Fistula Plug by Cook Biotech Incorporated — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2017
Date Received
January 3, 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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  • K161221 — Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (May 26, 2016)

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