FDA 510(k) Application Details - K060079

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

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510(K) Number K060079
Device Name System,X-Ray,Extraoral Source,Digital
Applicant EASTMAN KODAK COMPANY
343 STATE ST.
ROCHESTER, NY 14650 US
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Contact RAVI NABAR
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 01/10/2006
Decision Date 02/08/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K060079


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