The following data is part of a premarket notification filed by Omron Marshall Products, Inc. with the FDA for Omron Travel Toothbrush, Model Ht-b02.
| Device ID | K901963 |
| 510k Number | K901963 |
| Device Name: | OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02 |
| Classification | Toothbrush, Powered |
| Applicant | OMRON MARSHALL PRODUCTS, INC. 600 BARCLAY BLVD. Lincolnshire, IL 60069 |
| Contact | Casey Guzniczak |
| Correspondent | Casey Guzniczak OMRON MARSHALL PRODUCTS, INC. 600 BARCLAY BLVD. Lincolnshire, IL 60069 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-01 |
| Decision Date | 1990-06-26 |