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 |