The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Kerr Discovery Disposable Fluoride Tray.
Device ID | K780712 |
510k Number | K780712 |
Device Name: | KERR DISCOVERY DISPOSABLE FLUORIDE TRAY |
Classification | Tray, Fluoride, Disposable |
Applicant | KERR CORPORATION (DANBURY) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KMT |
CFR Regulation Number | 872.6870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-26 |
Decision Date | 1978-05-17 |