The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Tytin Admix.
Device ID | K951511 |
510k Number | K951511 |
Device Name: | TYTIN ADMIX |
Classification | Alloy, Amalgam |
Applicant | KERR CORPORATION (DANBURY) 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
Contact | Jeffrey A Anderson |
Correspondent | Jeffrey A Anderson KERR CORPORATION (DANBURY) 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
Product Code | EJJ |
CFR Regulation Number | 872.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-03 |
Decision Date | 1995-05-02 |