The following data is part of a premarket notification filed by Satalec-acteon Group with the FDA for Piezotome M+, Piezotome M+ Handpiece.
| Device ID | K163610 |
| 510k Number | K163610 |
| Device Name: | PIEZOTOME M+, PIEZOTOME M+ Handpiece |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | SATALEC-ACTEON GROUP 17 AVENUE GUSTAVE EIFFEL Merignac, FR 33708 |
| Contact | Philippe Girard |
| Correspondent | Argie Zoubroulis SATELEC- ACTEON GROUP 124 GAITHER DRIVE SUITE #140 Mt. Laurel, NJ 08054 |
| 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 | 2016-12-22 |
| Decision Date | 2017-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03609820879871 | K163610 | 000 |
| 03609820879734 | K163610 | 000 |
| 03609820879741 | K163610 | 000 |
| 03609820879789 | K163610 | 000 |
| 03609820879826 | K163610 | 000 |
| 03609820879833 | K163610 | 000 |
| 03609820879840 | K163610 | 000 |
| 03609820879857 | K163610 | 000 |
| 03609820879864 | K163610 | 000 |
| 03609820879727 | K163610 | 000 |