HOLLISTER PREMIUM URINE COLLECTOR

Device, Paste-on For Incontinence, Sterile

HOLLISTER, INC.

The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Premium Urine Collector.

Pre-market Notification Details

Device IDK931277
510k NumberK931277
Device Name:HOLLISTER PREMIUM URINE COLLECTOR
ClassificationDevice, Paste-on For Incontinence, Sterile
Applicant HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville,  IL  60048
ContactJoseph Tokarz
CorrespondentJoseph Tokarz
HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville,  IL  60048
Product CodeEXI  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-08
Decision Date1993-06-23

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