TOPAZ

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 Topaz.

Pre-market Notification Details

• Device ID: K960399
• 510k Number: K960399
• Device Name: TOPAZ
• Classification: Alloy, Gold-based Noble Metal
• Applicant: J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504
• Contact: Tridib Dasgupta
• Correspondent: Tridib Dasgupta; 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: 1996-01-29
• Decision Date: 1996-02-21