The following data is part of a premarket notification filed by John O. Butler with the FDA for Butler G.u.m. Antibacterial Toothbrush.
| Device ID | K950993 |
| 510k Number | K950993 |
| Device Name: | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH |
| Classification | Toothbrush, Manual |
| Applicant | JOHN O. BUTLER 4635 W. FOSTER AVE. Chicago, IL 60630 |
| Contact | Scott Koepsel |
| Correspondent | Scott Koepsel JOHN O. BUTLER 4635 W. FOSTER AVE. Chicago, IL 60630 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-03 |
| Decision Date | 1995-06-02 |