The following data is part of a premarket notification filed by Piezosurgery Srl with the FDA for Piezosurgery Device.
| Device ID | K043408 |
| 510k Number | K043408 |
| Device Name: | PIEZOSURGERY DEVICE |
| Classification | Drill, Bone, Powered |
| 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 | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2005-06-08 |
| Summary: | summary |