The following data is part of a premarket notification filed by Sodem Diffusion Sa with the FDA for Sodem High Speed System For Neurosurgery & Median Sternotomy.
| Device ID | K954717 |
| 510k Number | K954717 |
| Device Name: | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY |
| Classification | Motor, Drill, Pneumatic |
| 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 | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1997-01-22 |
| Summary: | summary |