CLEAR ADVANTAGE II

Device, Incontinence, Urosheath Type, Sterile

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Clear Advantage Ii.

Pre-market Notification Details

Device IDK945628
510k NumberK945628
Device Name:CLEAR ADVANTAGE II
ClassificationDevice, Incontinence, Urosheath Type, Sterile
Applicant MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara,  CA  93111
ContactByron H Wicket
CorrespondentByron H Wicket
MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara,  CA  93111
Product CodeEXJ  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-16
Decision Date1995-07-06

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