The following data is part of a premarket notification filed by Spelna, Inc. with the FDA for Satelec Suprasson Piezomatic P2.
| Device ID | K832664 |
| 510k Number | K832664 |
| Device Name: | SATELEC SUPRASSON PIEZOMATIC P2 |
| Classification | Scaler, Ultrasonic |
| Applicant | SPELNA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-09 |
| Decision Date | 1984-03-16 |