510(k) K944778
- Device
- LATEX EXAMINATION GLOVES
- Applicant
- PT. HALONI JANE
- 510(k) number
- K944778
- Product code
- OPE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-11-17
- Date received
- 1994-09-27
- Regulation
- 510(k) Premarket Notification
- Classification name
- 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
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LIPINY KUWANTO
- Address
- 8-I, Jalan Kapten Maulana Lubis Dalam Medan ID 20112 20112
FDA Registration Numbers#
- 2032112
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases