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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact DANIEL HOEFER
Regulation Number872.1800
Classification Product Code
MUH  
Date Received06/13/2011
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
Predetermined Change
Control Plan Authorized		 No
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