FDA 510(k), K080355, LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS

510(K) Number: K080355
Device Name: LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
Manufacturer: ELEKTA INSTRUMENT AB
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 02/11/2008
Decision Date: 05/01/2009
Regulation Medical Specialty: Neurology

203 pages (497 of 700 original pages are fully redacted)