The following data is part of a premarket notification filed by John O. Butler Co. with the FDA for Butler Gum Vari-clean Power Toothbrushes.
| Device ID | K022900 |
| 510k Number | K022900 |
| Device Name: | BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES |
| Classification | Toothbrush, Powered |
| Applicant | JOHN O. BUTLER CO. 4635 W. FOSTER AVE. Chicago, IL 60630 |
| Contact | Kevin G Yost |
| Correspondent | Kevin G Yost JOHN O. BUTLER CO. 4635 W. FOSTER AVE. Chicago, IL 60630 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2002-11-14 |
| Summary: | summary |