LATEX EXAMINATION GLOVES

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PT. HALONI JANE

The following data is part of a premarket notification filed by Pt. Haloni Jane with the FDA for Latex Examination Gloves.

Pre-market Notification Details

Device IDK944778
510k NumberK944778
Device Name:LATEX EXAMINATION GLOVES
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 PT. HALONI JANE 8-I, JALAN KAPTEN MAULANA LUBIS DALAM Medan,  ID 20112
ContactLipiny Kuwanto
CorrespondentLipiny Kuwanto
PT. HALONI JANE 8-I, JALAN KAPTEN MAULANA LUBIS DALAM Medan,  ID 20112
Product CodeOPE
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-27
Decision Date1994-11-17

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