The following data is part of a premarket notification filed by Mectron Spa with the FDA for Compact Piezo Led.
| Device ID | K151023 |
| 510k Number | K151023 |
| Device Name: | COMPACT PIEZO LED |
| Classification | Scaler, Ultrasonic |
| Applicant | MECTRON SPA VIA LORETO 15 Carasco, IT 16042 |
| Contact | Franco Zunino |
| Correspondent | Roger Gray DONAWA LIFESCIENCE CONSULTING 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 | 2015-04-16 |
| Decision Date | 2015-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E322029600090010 | K151023 | 000 |
| E322050900080120 | K151023 | 000 |
| E322050900080110 | K151023 | 000 |
| E322040000910 | K151023 | 000 |
| E322031201420010 | K151023 | 000 |
| E322029600090 | K151023 | 000 |