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510(k) K140562

WIJAY EZ-VOID EXTERNAL CATHETER VALVE by Leomed, LLC — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2014
Date Received
March 5, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K052298 — CYSTOGLIDE INTRODUCER SHEATH (December 12, 2006)