GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.

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

ASSOCIATED ENT., INC.

The following data is part of a premarket notification filed by Associated Ent., Inc. with the FDA for Glove Check Patient Examination Glove Leak Detect..

Pre-market Notification Details

• Device ID: K915636
• 510k Number: K915636
• Device Name: GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.
• Classification: 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
• Applicant: ASSOCIATED ENT., INC. 623 CHARLIE HICKS RD. Jonesborough, TN 37659
• Contact: Eddi Leach
• Correspondent: Eddi Leach; ASSOCIATED ENT., INC. 623 CHARLIE HICKS RD. Jonesborough, TN 37659
• Product Code: LDQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-12-17
• Decision Date: 1992-07-13