SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030

510(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 Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

KLEEN TEST PRODUCTS

The following data is part of a premarket notification filed by Kleen Test Products with the FDA for Sure Count 30 Count Foam & Magnetic 92-3030.

Pre-market Notification Details

Device IDK853622
510k NumberK853622
Device Name:SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030
Classification510(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 Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant KLEEN TEST PRODUCTS 4425 W. WOOLWORTH AVE. P.O.B OX 574 Milwaukee,  WI  53218
ContactRick W Poenitsch
CorrespondentRick W Poenitsch
KLEEN TEST PRODUCTS 4425 W. WOOLWORTH AVE. P.O.B OX 574 Milwaukee,  WI  53218
Product Code510(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 Radiation-Emitting Products Vaccines, Blood &
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-29
Decision Date1985-10-10

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