The following data is part of a premarket notification filed by Colgate-hoyt Laboratories with the FDA for Top Form Ii Trays, Dispos Foam-lined Top Gel Appli.
| Device ID | K871784 |
| 510k Number | K871784 |
| Device Name: | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI |
| Classification | Tray, Fluoride, Disposable |
| Applicant | COLGATE-HOYT LABORATORIES ONE COLGATE WAY Canton, MA 02021 |
| Contact | John J Vozella |
| Correspondent | John J Vozella COLGATE-HOYT LABORATORIES ONE COLGATE WAY Canton, MA 02021 |
| Product Code | KMT |
| CFR Regulation Number | 872.6870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-06 |
| Decision Date | 1987-05-27 |