The following data is part of a premarket notification filed by Satelec - Acteon, Inc. with the FDA for Piezotome Solo.
| Device ID | K112188 |
| 510k Number | K112188 |
| Device Name: | PIEZOTOME SOLO |
| Classification | Drill, Bone, Powered |
| Applicant | SATELEC - ACTEON, INC. 124 GAITHER DR., SUITE 140 Mount Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SATELEC - ACTEON, INC. 124 GAITHER DR., SUITE 140 Mount Laurel, NJ 08054 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-29 |
| Decision Date | 2012-02-03 |
| Summary: | summary |