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510(k) K100313

HYDROFIX SURGICAL SHEET by Mimedx Group, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2011
Date Received
February 4, 2010
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 Mimedx Group, Inc.

  • K111137 — HYDROFIX VASO SHIELD (May 20, 2011)
  • K101805 — HYDROFIX VASO SHIELD (April 8, 2011)
  • K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (July 28, 2010)
  • K100905 — HYDROFIX SURGICAL SHEET (June 2, 2010)

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