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510(k) K081327

RELIMESH by Herniamesh S.R.L. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2008
Date Received
May 12, 2008
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 Herniamesh S.R.L.

  • K050516 — T-SLING (February 3, 2006)
  • K020652 — HERNIAMESH T-SLING (May 15, 2002)
  • K973955 — HERNIAMESH SURGICAL MESHES (May 11, 1998)

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