510(k) K945628

CLEAR ADVANTAGE II by Mentor Corp. — Product Code EXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1995
Date Received
November 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Incontinence, Urosheath Type, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type