The following data is part of a premarket notification filed by Mectron S.p.a. with the FDA for Piezosurgery Touch.
| Device ID | K122322 |
| 510k Number | K122322 |
| Device Name: | PIEZOSURGERY TOUCH |
| Classification | Drill, Bone, Powered |
| Applicant | MECTRON S.P.A. PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray MECTRON S.P.A. PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E322051200620300 | K122322 | 000 |
| E322051200620280 | K122322 | 000 |
| E322040000860 | K122322 | 000 |
| E322034000100 | K122322 | 000 |
| E322034000090 | K122322 | 000 |
| E322034000080 | K122322 | 000 |
| E322033800141010 | K122322 | 000 |
| E322033700290 | K122322 | 000 |