TYTIN

Alloy, Amalgam

KERR CORPORATION (DANBURY)

The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Tytin.

Pre-market Notification Details

• Device ID: K935535
• 510k Number: K935535
• Device Name: TYTIN
• Classification: Alloy, Amalgam
• Applicant: KERR CORPORATION (DANBURY) 1332 SOUTH LONE HILL AVE. Glendora, CA 91740
• Contact: Larry Wills
• Correspondent: Larry Wills; KERR CORPORATION (DANBURY) 1332 SOUTH LONE HILL AVE. Glendora, CA 91740
• Product Code: EJJ
• Subsequent Product Code: DZS
• Subsequent Product Code: ELY
• CFR Regulation Number: 872.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-11-16
• Decision Date: 1994-03-11