EQUITY

Alloy, Gold-based Noble Metal

JENSEN INDUSTRIES, INC.

The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for Equity.

Pre-market Notification Details

• Device ID: K002826
• 510k Number: K002826
• Device Name: EQUITY
• Classification: Alloy, Gold-based Noble Metal
• Applicant: JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473
• Contact: John Slanski
• Correspondent: John Slanski; JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473
• Product Code: EJT
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-09-11
• Decision Date: 2000-10-24