The following data is part of a premarket notification filed by Piezosurgery Srl with the FDA for Piezosurgery.
| Device ID | K052518 |
| 510k Number | K052518 |
| Device Name: | PIEZOSURGERY |
| Classification | Scaler, Ultrasonic |
| Applicant | PIEZOSURGERY SRL PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Maria E Donawa |
| Correspondent | Maria E Donawa PIEZOSURGERY SRL PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2005-11-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PIEZOSURGERY 85337465 4181946 Live/Registered |
Piezosurgery Incorporated 2011-06-03 |
![]() PIEZOSURGERY 85337455 4181945 Live/Registered |
Piezosurgery Incorporated 2011-06-03 |
![]() PIEZOSURGERY 76149906 3006803 Live/Registered |
MECTRON S.P.A. 2000-10-19 |