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510(k) K043259

BIOBLANKET SURGICAL MESH by Kensey Nash Corp. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2005
Date Received
November 24, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

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  • K073519 — QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 (March 28, 2008)
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  • K072195 — THROMCAT THROMBECTOMY CATHETER SYSTEM (August 23, 2007)
  • K071237 — COPIOS BONE VOID FILLER SPONGE AND PASTE (June 1, 2007)
  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)

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