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510(k) K050678

MOTIFMESH SOFT TISSUE PATCH by Proxy Biomedical , Ltd. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2005
Date Received
March 16, 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 Proxy Biomedical , Ltd.

  • K172636 — VitaMESH Macroporous PP Surgical Mesh (April 30, 2018)
  • K111121 — VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH (May 13, 2011)
  • K060520 — VITAMESH MACROPOROUS PP SURGICAL MESH (March 28, 2006)
  • K052100 — MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH (August 11, 2005)
  • K051245 — POLYFORM SYNTHETIC MESH (June 17, 2005)

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