SwabTip Male Disinfectant Cap

Cap, Device Disinfectant

ICU Medical

The following data is part of a premarket notification filed by Icu Medical with the FDA for Swabtip Male Disinfectant Cap.

Pre-market Notification Details

Device IDK190918
510k NumberK190918
Device Name:SwabTip Male Disinfectant Cap
ClassificationCap, Device Disinfectant
Applicant ICU Medical 600 N. Field Drive Lake Forest,  IL  60045
ContactNichelle Cato
CorrespondentNichelle Cato
ICU Medical 600 N. Field Drive Lake Forest,  IL  60045
Product CodeQBP  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
510k Review PanelGeneral Hospital
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-09
Decision Date2020-03-06

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