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510(k) K080022

GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP by Vascular Solutions, Inc. — Product Code KHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2008
Date Received
January 3, 2008
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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