The following data is part of a premarket notification filed by Ohio Health Care Products, Inc. with the FDA for Oral Ease Automatic Flosser/power Brush.
| Device ID | K936076 |
| 510k Number | K936076 |
| Device Name: | ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH |
| Classification | Toothbrush, Powered |
| Applicant | OHIO HEALTH CARE PRODUCTS, INC. 9024-C EUCLID AVE. Manassas, VA 22110 |
| Contact | Martin J Cohen |
| Correspondent | Martin J Cohen OHIO HEALTH CARE PRODUCTS, INC. 9024-C EUCLID AVE. Manassas, VA 22110 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1994-01-26 |