Home / 510(k) Clearances / K191696

510(k) K191696

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft by Cook Biotech Incorporated — Product Code OXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2019
Date Received
June 25, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Collagen, Fistula
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists during the repair of fistulas.

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