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510(k) K063739

SEPRAMESH, MODEL 5959-1214 by Genzyme Corporation — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2007
Date Received
December 18, 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

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  • K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT (July 11, 2005)

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