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510(k) K052830

SPORTMESH by Artimplant AB — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2006
Date Received
October 5, 2005
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

Other clearances by Artimplant AB

  • K071887 — SPORTMESH OR ARTELON TISSUE REINFORCEMENT (September 18, 2007)
  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K061954 — ARTELON CMC SPACER ARTHRO (June 1, 2007)
  • K052482 — ARTELON SURGICAL SUTURE (October 17, 2005)
  • K040070 — ARTELON SPACER CMC-1 (September 21, 2004)
  • K032160 — ARTELON SURGICAL SUTURE (November 17, 2003)

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