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510(k) K071887

SPORTMESH OR ARTELON TISSUE REINFORCEMENT by Artimplant AB — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2007
Date Received
July 9, 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

Other clearances by Artimplant AB

  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K061954 — ARTELON CMC SPACER ARTHRO (June 1, 2007)
  • K052830 — SPORTMESH (January 19, 2006)
  • 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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