The following data is part of a premarket notification filed by Hoyt Laboratories with the FDA for Hoyt Econo-tray.
Device ID | K811154 |
510k Number | K811154 |
Device Name: | HOYT ECONO-TRAY |
Classification | Tray, Fluoride, Disposable |
Applicant | HOYT LABORATORIES 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 | 1981-04-28 |
Decision Date | 1981-05-13 |