The following data is part of a premarket notification filed by Satelec with the FDA for Sp4044 & Sp4055 Lux Modules.
| Device ID | K972026 |
| 510k Number | K972026 |
| Device Name: | SP4044 & SP4055 LUX MODULES |
| Classification | Scaler, Ultrasonic |
| Applicant | SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Contact | Jackie Masse |
| Correspondent | Jackie Masse SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-07-09 |
| Summary: | summary |