SURGICASE GUIDE


Device Classification Name

neurological stereotaxic instrument

510(k) Number K111558
Device Name SURGICASE GUIDE
Applicant
MATERIALISE N.V.
technologielaan 15
leuven, 

BE

3001

Applicant Contact alexandra razzhivina
Correspondent
MATERIALISE N.V.
technologielaan 15
leuven, 

BE

3001

Correspodent Contact alexandra razzhivina
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 06/03/2011
Decision Date 03/27/2012
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