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510(k) K201000

Biodesign Staple Line Reinforcement by Cook Biotech Incorporated — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2020
Date Received
April 16, 2020
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

Other clearances by Cook Biotech Incorporated

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  • K171817 — Biodesign Diaphragmatic Hernia Graft (March 13, 2018)
  • K162934 — Biodesign Parastomal Hernia Repair Graft (July 10, 2017)
  • K170016 — Biodesign Fistula Plug (June 21, 2017)
  • K170945 — Biodesign Staple Line Reinforcement (April 28, 2017)
  • K161762 — DynaMatrix/Dynamatrix Plus (January 13, 2017)
  • K162741 — AxoGuard Nerve Connector (October 31, 2016)
  • K160136 — Flowable Wound Matrix (September 28, 2016)
  • K161221 — Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (May 26, 2016)

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