Home / 510(k) Clearances / K161221

510(k) K161221

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug by Cook Biotech Incorporated — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2016
Date Received
April 29, 2016
Clearance Type
Special
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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  • K161762 — DynaMatrix/Dynamatrix Plus (January 13, 2017)
  • K162741 — AxoGuard Nerve Connector (October 31, 2016)
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