JOHNS-ALLGOOD IRRIVAC DRIVE-IRRIGATOR/ASPIRATOR-

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

DEXIDE, INC.

The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Johns-allgood Irrivac Drive-irrigator/aspirator-.

Pre-market Notification Details

Device IDK854072
510k NumberK854072
Device Name:JOHNS-ALLGOOD IRRIVAC DRIVE-IRRIGATOR/ASPIRATOR-
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 DEXIDE, INC. P.O. BOX 185789 Ft. Worth,  TX  76181
ContactMary K Bruch
CorrespondentMary K Bruch
DEXIDE, INC. P.O. BOX 185789 Ft. Worth,  TX  76181
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 Received1985-10-04
Decision Date1985-11-15

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