The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Leksell Surgiplan.
| Device ID | K943468 |
| 510k Number | K943468 |
| Device Name: | LEKSELL SURGIPLAN |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Contact | Tom Parker |
| Correspondent | Tom Parker ELEKTA INSTRUMENTS, INC. 8 EXECUTIVE PARK WEST Atlanta, GA 30329 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1995-01-20 |