The following data is part of a premarket notification filed by Cost Rite Health Products, Inc. with the FDA for Carerite Interdental Brushes, Models 3500 & 4500.
| Device ID | K870906 |
| 510k Number | K870906 |
| Device Name: | CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500 |
| Classification | Toothbrush, Manual |
| Applicant | COST RITE HEALTH PRODUCTS, INC. 9428 ETON AVE. UNIT "F" Chatsworth, CA 91311 |
| Contact | Israel Ben-tzur |
| Correspondent | Israel Ben-tzur COST RITE HEALTH PRODUCTS, INC. 9428 ETON AVE. UNIT "F" Chatsworth, CA 91311 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-05 |
| Decision Date | 1987-03-30 |