FDA 510(k) Application Details - K073696

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

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510(K) Number K073696
Device Name System,X-Ray,Extraoral Source,Digital
Applicant J. MORITA USA, INC.
1425 K ST. N.W.
SUITE 1100
WASHINGTON, DC 20005 US
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Contact KEITH A BARRITT
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Regulation Number 872.1800

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Classification Product Code MUH
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Date Received 12/31/2007
Decision Date 04/08/2008
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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