The following data is part of a premarket notification filed by Satelec with the FDA for Piezotome 2.
| Device ID | K091331 |
| 510k Number | K091331 |
| Device Name: | PIEZOTOME 2 |
| Classification | Drill, Bone, Powered |
| Applicant | SATELEC 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SATELEC 124 GAITHER DRIVE SUITE 140 Mt. 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 | 2009-05-05 |
| Decision Date | 2009-12-11 |
| Summary: | summary |