SURGICASE ORTHOGNATHIC SOFTWARE WIZARD


Device Classification Name

system, image processing, radiological

510(k) Number K111641
Device Name SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
Applicant
MATERIALISE N.V.
technologielaan 15
leuven, 

BE

3001

Applicant Contact oliver clemens
Correspondent
MATERIALISE N.V.
technologielaan 15
leuven, 

BE

3001

Correspodent Contact oliver clemens
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/13/2011
Decision Date 09/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No