The following data is part of a premarket notification filed by Satelec with the FDA for Dissectron Portable Unit.
| Device ID | K972612 |
| 510k Number | K972612 |
| Device Name: | DISSECTRON PORTABLE UNIT |
| Classification | Device, Neurosurgical Fragmentation And Aspiration |
| Applicant | SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Contact | Jackie Masse |
| Correspondent | Jackie Masse SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Product Code | LBK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1997-10-08 |
| Summary: | summary |