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510(k) K050008

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2005
Date Received
January 3, 2005
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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