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510(k) K103086

DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC by Dynarex Corporation — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2011
Date Received
October 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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