The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Modification To Leksell Surgiplan With Atlaspace.
| Device ID | K013861 |
| 510k Number | K013861 |
| Device Name: | MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ELEKTA INSTRUMENT AB 21911 ERIE LN. Lake Forest, CA 92630 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson ELEKTA INSTRUMENT AB 21911 ERIE LN. Lake Forest, CA 92630 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-21 |
| Decision Date | 2001-12-06 |
| Summary: | summary |