The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Reach Antibacterial Toothbrush.
| Device ID | K971589 |
| 510k Number | K971589 |
| Device Name: | REACH ANTIBACTERIAL TOOTHBRUSH |
| Classification | Toothbrush, Manual |
| Applicant | PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Contact | Lorna-jane Bremer |
| Correspondent | Lorna-jane Bremer PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-07-24 |
| Summary: | summary |