ValPro 2 Plus, VaPro 2 Plus Pocket

Catheter, Urethral

Hollister Incorporated

The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Valpro 2 Plus, Vapro 2 Plus Pocket.

Pre-market Notification Details

Device IDK183253
510k NumberK183253
Device Name:ValPro 2 Plus, VaPro 2 Plus Pocket
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 Received2018-11-21
Decision Date2018-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00610075054039 K183253 000
00610075054015 K183253 000
00610075054008 K183253 000
00610075053995 K183253 000
00610075053988 K183253 000
00610075065332 K183253 000

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