CS 7600


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K111649
Device Name CS 7600
Applicant
CARESTREAM HEALTH, INC.
1765 the exchange
atlanta, 
GA 
30339

Applicant Contact daniel hoefer
Correspondent
CARESTREAM HEALTH, INC.
1765 the exchange
atlanta, 
GA 
30339

Correspodent Contact daniel hoefer
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 06/13/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No