The following data is part of a premarket notification filed by Sodem Diffusion Sa with the FDA for Sodem High Speed System.
| Device ID | K954080 |
| 510k Number | K954080 |
| Device Name: | SODEM HIGH SPEED SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | SODEM DIFFUSION SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson SODEM DIFFUSION SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-31 |
| Decision Date | 1995-10-16 |