EXTERNAL INCONTINENCE CATHETER TAKE-HOME

Collector, Urine, (and Accessories) For Indwelling Catheter

PLASCO, INC.

The following data is part of a premarket notification filed by Plasco, Inc. with the FDA for External Incontinence Catheter Take-home.

Pre-market Notification Details

Device IDK832109
510k NumberK832109
Device Name:EXTERNAL INCONTINENCE CATHETER TAKE-HOME
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant PLASCO, 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 Received1983-06-29
Decision Date1983-07-18

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