IGI-SYSTEM


Device Classification Name

neurological stereotaxic instrument

510(k) Number K023424
Device Name IGI-SYSTEM
Original Applicant
DENX ADVANCED DENTAL SYSTEMS
mizpe aviv, industrial park 13
m.p. misgav, 

IL

20187

Original Contact koby ben-barak
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 10/11/2002
Decision Date 05/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No