The following data is part of a premarket notification filed by Fran Hazelton Co. with the FDA for Hazelton Temporary Crown And Bridge Remover.
| Device ID | K854795 |
| 510k Number | K854795 |
| Device Name: | HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER |
| Classification | Remover, Crown |
| Applicant | FRAN HAZELTON CO. 919 FIRST ST. ORLAND, CA 95963 |
| Contact | FRANCES M HAZELTON |
| Correspondent | FRANCES M HAZELTON FRAN HAZELTON CO. 919 FIRST ST. ORLAND, CA 95963 |
| Product Code | EIS |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-02 |
| Decision Date | 1986-03-04 |