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510(k) K052440

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER by Mentor Corporation — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2005
Date Received
September 6, 2005
Clearance Type
Special
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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  • K050148 — MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT (March 9, 2005)

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