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510(k) K043035

SEPRAGEL ENT BIORESORBABLE PACKING/STENT by Genzyme Corporation — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2005
Date Received
November 3, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

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