The following data is part of a premarket notification filed by Piezosurgery Srl with the FDA for Piezosurgery Medical.
| Device ID | K083284 |
| 510k Number | K083284 |
| Device Name: | PIEZOSURGERY MEDICAL |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | PIEZOSURGERY SRL PIAZZA ALBANIA 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray PIEZOSURGERY SRL PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | JDX |
| Subsequent Product Code | DZI |
| Subsequent Product Code | ERL |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HWE |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-07 |
| Decision Date | 2009-04-08 |
| Summary: | summary |