The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Lee-alloy.
Device ID | K780967 |
510k Number | K780967 |
Device Name: | LEE-ALLOY |
Classification | Alloy, Amalgam |
Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJJ |
CFR Regulation Number | 872.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-12 |
Decision Date | 1978-06-22 |