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510(k) K061473

SURGI-WRAP MAST BIORESORBABLE SHEET by Mast Biosurgery USA, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2006
Date Received
May 30, 2006
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 Mast Biosurgery USA, Inc.

  • K090637 — CARDIO-WRAP (January 7, 2010)
  • K063648 — SURGI-WRAP MAST TENDON SHEET (March 7, 2007)
  • K050332 — SURGI-WRAP MAST BIORESORBABLE SHEET (May 27, 2005)

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