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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K111423
Device Name CS 1600 INTRAORAL CAMERA
Applicant
CARESTREAM HEALTH,INC.
1765 THE EXCHANGE
ATLANTA,  GA  30339
Applicant Contact DANIEL HOEFER
Correspondent
CARESTREAM HEALTH,INC.
1765 THE EXCHANGE
ATLANTA,  GA  30339
Correspondent Contact DANIEL HOEFER
Regulation Number872.1745
Classification Product Code
NBL  
Date Received05/23/2011
Decision Date 03/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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