DOMINION

Alloy, Gold-based Noble Metal

UNITEK CORP.

The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Dominion.

Pre-market Notification Details

• Device ID: K831098
• 510k Number: K831098
• Device Name: DOMINION
• Classification: Alloy, Gold-based Noble Metal
• Applicant: UNITEK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EJT
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-04-04
• Decision Date: 1983-06-16