SILICONE MALE EXTERNAL CATHETER

Device, Incontinence, Urosheath Type, Sterile

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Silicone Male External Catheter.

Pre-market Notification Details

Device IDK913524
510k NumberK913524
Device Name:SILICONE MALE EXTERNAL CATHETER
ClassificationDevice, Incontinence, Urosheath Type, Sterile
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactByron H Wickett
CorrespondentByron H Wickett
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeEXJ  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-08
Decision Date1991-10-04

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