LEKSELL SURGIPLAN, MODEL 1006947


Device Classification Name

neurological stereotaxic instrument

510(k) Number K080250
Device Name LEKSELL SURGIPLAN, MODEL 1006947
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 01/31/2008
Decision Date 05/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No