The following data is part of a premarket notification filed by Sodemsystems with the FDA for Sodem Power System.
| Device ID | K935567 |
| 510k Number | K935567 |
| Device Name: | SODEM POWER SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | SODEMSYSTEMS 49 PLAIN ST. North Attleboro, MA 02763 |
| Contact | Rosina Robinson, R.n. |
| Correspondent | Rosina Robinson, R.n. SODEMSYSTEMS 49 PLAIN ST. North Attleboro, MA 02763 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-01-21 |