ACU-HALT

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

GLEDERER & CO., INC.

The following data is part of a premarket notification filed by Glederer & Co., Inc. with the FDA for Acu-halt.

Pre-market Notification Details

• Device ID: K955661
• 510k Number: K955661
• Device Name: ACU-HALT
• 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: GLEDERER & CO., INC. 503 EAST 40TH ST. Paterson, NJ 07504
• Contact: Gabe Lederer
• Correspondent: Gabe Lederer; GLEDERER & CO., INC. 503 EAST 40TH ST. Paterson, NJ 07504
• 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: 1995-12-12
• Decision Date: 1996-12-30