FDA 510(k) Application Details - K111649

Device Classification Name System,X-Ray,Extraoral Source,Digital

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510(K) Number K111649
Device Name System,X-Ray,Extraoral Source,Digital
Applicant CARESTREAM HEALTH, INC.
1765 THE EXCHANGE
ATLANTA, GA 30339 US
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Contact DANIEL HOEFER
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 06/13/2011
Decision Date 09/23/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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