MALE EXTERNAL CATHETER

Collector, Urine, (and Accessories) For Indwelling Catheter

UROCARE PRODUCTS, INC.

The following data is part of a premarket notification filed by Urocare Products, Inc. with the FDA for Male External Catheter.

Pre-market Notification Details

Device IDK820565
510k NumberK820565
Device Name:MALE EXTERNAL CATHETER
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant UROCARE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKNX  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-03-02
Decision Date1982-04-01

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