510(k) K050777

PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 by Conmedcorp — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2005
Date Received
March 28, 2005
Clearance Type
Special
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