The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Surgiplan, Model 1006947.
| Device ID | K080250 |
| 510k Number | K080250 |
| Device Name: | LEKSELL SURGIPLAN, MODEL 1006947 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-103 93 |
| Contact | Peter Lowendahl |
| Correspondent | Peter Lowendahl ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm, SE S-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 | 2008-01-31 |
| Decision Date | 2008-05-13 |
| Summary: | summary |