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510(k) K043581

DUAL LUMEN CATHETER by Acmi Corporation — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2005
Date Received
December 28, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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