VAPRO INTERMITTENT CATHETER

Catheter, Urethral

HOLLISTER, INCORPORATED

The following data is part of a premarket notification filed by Hollister, Incorporated with the FDA for Vapro Intermittent Catheter.

Pre-market Notification Details

Device IDK141642
510k NumberK141642
Device Name:VAPRO INTERMITTENT CATHETER
ClassificationCatheter, Urethral
Applicant HOLLISTER, INCORPORATED 2000 HOLLISTER DRIVE Libertyville,  IL  60048
ContactJeanne Lee
CorrespondentJeanne Lee
HOLLISTER, INCORPORATED 2000 HOLLISTER DRIVE Libertyville,  IL  60048
Product CodeGBM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-19
Decision Date2014-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00610075080588 K141642 000

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