ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR

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

MANAN MANUFACTURING CO., INC.

The following data is part of a premarket notification filed by Manan Manufacturing Co., Inc. with the FDA for Arthrogram Tray For Double & Single Contrast Arthr.

Pre-market Notification Details

Device IDK852018
510k NumberK852018
Device Name:ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR
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 MANAN MANUFACTURING CO., INC. 8020 NORTH CENTRAL PARK AVE. Skokie,  IL  60076
ContactManfred Mittermeir
CorrespondentManfred Mittermeir
MANAN MANUFACTURING CO., INC. 8020 NORTH CENTRAL PARK AVE. Skokie,  IL  60076
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 - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-08
Decision Date1985-07-11

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