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510(k) K111121

VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH by Proxy Biomedical , Ltd. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2011
Date Received
April 21, 2011
Clearance Type
Special
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.

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  • K051245 — POLYFORM SYNTHETIC MESH (June 17, 2005)
  • K050678 — MOTIFMESH SOFT TISSUE PATCH (May 20, 2005)

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