CS 1200


Device Classification Name

unit, operative dental

510(k) Number K112321
Device Name CS 1200
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 872.6640
Classification Product Code
EIA  
Date Received 08/12/2011
Decision Date 11/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No