MEDALIST

Alloy, Gold-based Noble Metal

J.F. JELENKO & CO., INC.

The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Medalist.

Pre-market Notification Details

• Device ID: K944888
• 510k Number: K944888
• Device Name: MEDALIST
• Classification: Alloy, Gold-based Noble Metal
• Applicant: J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504
• Contact: Paul J Cascone
• Correspondent: Paul J Cascone; J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504
• Product Code: EJT
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-04
• Decision Date: 1994-11-07