VaPro Plus Pocket, VaPro Plus

Catheter, Urethral

Hollister Incorporated

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

Pre-market Notification Details

Device IDK193148
510k NumberK193148
Device Name:VaPro Plus Pocket, VaPro Plus
ClassificationCatheter, Urethral
Applicant Hollister Incorporated 2000 Hollister Drive Libertyville,  IL  60048
ContactMichelle Schiltz-taing
CorrespondentMichelle Schiltz-taing
Hollister Incorporated 2000 Hollister Drive Libertyville,  IL  60048
Product CodeGBM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-13
Decision Date2019-12-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00610075068760 K193148 000

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