CHALLENGER

Alloy, Other Noble Metal

BAUER, CHENG & ASSOCIATES, INC.

The following data is part of a premarket notification filed by Bauer, Cheng & Associates, Inc. with the FDA for Challenger.

Pre-market Notification Details

• Device ID: K823084
• 510k Number: K823084
• Device Name: CHALLENGER
• Classification: Alloy, Other Noble Metal
• Applicant: BAUER, CHENG & ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EJS
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-10-19
• Decision Date: 1982-11-10