LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS


Device Classification Name

neurological stereotaxic instrument

510(k) Number K080355
Device Name LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
Applicant
ELEKTA INSTRUMENT AB
kungstensgatan 18
p.o.box 7593
stockholm, 

SE

s-103 93

Applicant Contact peter lowendahl
Correspondent
ELEKTA INSTRUMENT AB
kungstensgatan 18
p.o.box 7593
stockholm, 

SE

s-103 93

Correspodent Contact peter lowendahl
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 02/11/2008
Decision Date 05/01/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No