The following data is part of a premarket notification filed by Mectron Spa with the FDA for Multipiezo Pro, Multipiezo.
Device ID | K140965 |
510k Number | K140965 |
Device Name: | MULTIPIEZO PRO, MULTIPIEZO |
Classification | Scaler, Ultrasonic |
Applicant | MECTRON SPA PIAZZA ALBANIA, 10 Rome, IT 00153 |
Contact | Roger Gray |
Correspondent | Roger Gray MECTRON SPA 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 | 2014-04-15 |
Decision Date | 2014-08-20 |
Summary: | summary |