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510(k) K002650

VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 by Bentec Medical, Inc. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2001
Date Received
August 25, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Bentec Medical, Inc.

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