COOL.CLICK 2

Injector, Fluid, Non-electrically Powered

MEDICAL HOUSE PRODUCTS LIMITED

The following data is part of a premarket notification filed by Medical House Products Limited with the FDA for Cool.click 2.

Pre-market Notification Details

Device IDK060819
510k NumberK060819
Device Name:COOL.CLICK 2
ClassificationInjector, Fluid, Non-electrically Powered
Applicant MEDICAL HOUSE PRODUCTS LIMITED 199 NEWHALL ROAD Sheffield,  GB S9 2qj
ContactRose Y Guang
CorrespondentRose Y Guang
MEDICAL HOUSE PRODUCTS LIMITED 199 NEWHALL ROAD Sheffield,  GB S9 2qj
Product CodeKZE  
CFR Regulation Number880.5430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-27
Decision Date2006-06-16
Summary:summary

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