SIMPLANT 2011


Device Classification Name

system, image processing, radiological

510(k) Number K110300
Device Name SIMPLANT 2011
Applicant
MATERIALISE DENTAL NV
technologielaan 15
leuven, 

BE

3001

Applicant Contact peter vandeput
Correspondent
MATERIALISE DENTAL NV
technologielaan 15
leuven, 

BE

3001

Correspodent Contact peter vandeput
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/02/2011
Decision Date 07/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No