The following data is part of a premarket notification filed by Sas Group, Inc. with the FDA for Plustron Ion Toothbrush System.
| Device ID | K971639 |
| 510k Number | K971639 |
| Device Name: | PLUSTRON ION TOOTHBRUSH SYSTEM |
| Classification | Toothbrush, Ionic, Battery-powered |
| Applicant | SAS GROUP, INC. 220 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Contact | Michael D Sobo |
| Correspondent | Michael D Sobo SAS GROUP, INC. 220 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Product Code | MMD |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-02 |
| Decision Date | 1997-06-24 |