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510(k) K072520

TEPHAFLEX SURGICAL FILM by Tepha, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2007
Date Received
September 7, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K162922 — GalaFORM 3D (February 23, 2017)
  • K161092 — GalaSHAPE 3D (August 23, 2016)
  • K140533 — GALAFLEX MESH (May 21, 2014)
  • K132348 — TEPHAFLEX BRAIDED SUTURE (September 5, 2013)
  • K130326 — TEPHAFLEX MELTBLOWN CONSTRUCT (May 7, 2013)
  • K113721 — TEPHAFLEX LIGHT MESH (February 15, 2012)
  • K113723 — TEPHAFLEX MESH (February 15, 2012)

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  • K232373 — Progrip™ Self-Gripping Polypropylene Mesh (January 18, 2024)
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