ZENITH

Alloy, Metal, Base

JENERIC IND.

The following data is part of a premarket notification filed by Jeneric Ind. with the FDA for Zenith.

Pre-market Notification Details

• Device ID: K833145
• 510k Number: K833145
• Device Name: ZENITH
• Classification: Alloy, Metal, Base
• Applicant: JENERIC IND. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EJH
• CFR Regulation Number: 872.3710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-09-15
• Decision Date: 1983-11-28