THERAPY CASSETTS

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

ALPHA THERAPEUTIC CORP.

The following data is part of a premarket notification filed by Alpha Therapeutic Corp. with the FDA for Therapy Cassetts.

Pre-market Notification Details

• Device ID: K854920
• 510k Number: K854920
• Device Name: THERAPY CASSETTS
• 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: ALPHA THERAPEUTIC CORP. P.O. BOX 516 Rouses Point, NY 12979 -0516
• Contact: Stuart Gilman
• Correspondent: Stuart Gilman; ALPHA THERAPEUTIC CORP. P.O. BOX 516 Rouses Point, NY 12979 -0516
• Product Code: MCU
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-12-10
• Decision Date: 1986-05-19