The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Modification To Leksell Stereotactic System.
| Device ID | K031980 |
| 510k Number | K031980 |
| Device Name: | MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 PO BOX 7593 Stockholm, SE Se-103 93 |
| Contact | Peter Lowendahl |
| Correspondent | Peter Lowendahl ELEKTA INSTRUMENT AB BIRGER JARLSGATAN 53 PO BOX 7593 Stockholm, SE Se-103 93 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-26 |
| Decision Date | 2003-07-25 |