The following data is part of a premarket notification filed by Omron Healthcare, Inc. with the FDA for Omron Rechargeable Plaque Removal System #ht-b142.
| Device ID | K926246 |
| 510k Number | K926246 |
| Device Name: | OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142 |
| Classification | Toothbrush, Powered |
| Applicant | OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Contact | Frank Brichetto |
| Correspondent | Frank Brichetto OMRON HEALTHCARE, INC. 300 LAKEVIEW PKWY. Vernon Hills, IL 60061 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-14 |
| Decision Date | 1993-04-14 |