ENTERNAL FEEDING PUMP BATTERY OPER.

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

FRESENIUS USA, INC.

The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Enternal Feeding Pump Battery Oper..

Pre-market Notification Details

Device IDK841104
510k NumberK841104
Device Name:ENTERNAL FEEDING PUMP BATTERY OPER.
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 FRESENIUS USA, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
ContactRainer K Cremerius
CorrespondentRainer K Cremerius
FRESENIUS USA, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
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 Received1984-03-14
Decision Date1985-04-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.