The following data is part of a premarket notification filed by Sodem Systems with the FDA for Modification To Sodem High Speed System For Neurosurgical Use.
| Device ID | K994175 |
| 510k Number | K994175 |
| Device Name: | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE |
| Classification | Motor, Drill, Pneumatic |
| Applicant | SODEM SYSTEMS 110 CH. DU PONT DU CENTENAIRE Geneva, CH Ch-1228 |
| Contact | Daniel Baccino |
| Correspondent | Daniel Baccino SODEM SYSTEMS 110 CH. DU PONT DU CENTENAIRE Geneva, CH Ch-1228 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-10 |
| Decision Date | 1999-12-21 |