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510(k) K040829

GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR by Vascutek, Ltd. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2004
Date Received
March 31, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

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