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510(k) K031360

GI SUPPLY BILIARY STENT by Gi Supply — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2003
Date Received
April 30, 2003
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

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