MODIFICATION TO FOCUS


Device Classification Name

unit, x-ray, extraoral with timer

510(k) Number K022630
Device Name MODIFICATION TO FOCUS
Original Applicant
INSTRUMENTARIUM CORP.
300 west edgerton ave.
milwaukee, 
WI 
53207

Original Contact mark mason
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 08/07/2002
Decision Date 10/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls