The following data is part of a premarket notification filed by Electro Medical Systems (ems Sa) with the FDA for Piezon Master 400.
| Device ID | K896749 |
| 510k Number | K896749 |
| Device Name: | PIEZON MASTER 400 |
| Classification | Scaler, Ultrasonic |
| Applicant | ELECTRO MEDICAL SYSTEMS (EMS SA) CH. DE LA VUARPILLIERE 31 Nyon, Vaud, CH Ch-1260 |
| Contact | Simpson |
| Correspondent | Simpson ELECTRO MEDICAL SYSTEMS (EMS SA) CH. DE LA VUARPILLIERE 31 Nyon, Vaud, CH Ch-1260 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-30 |
| Decision Date | 1990-08-31 |