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FDA 510(k) Application Details - K073695
Device Classification Name
System, X-Ray, Tomography, Computed
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510(K) Number
K073695
Device Name
System, X-Ray, Tomography, Computed
Applicant
J. MORITA USA, INC.
1425 K ST. N.W.
SUITE 1100
WASHINGTON, DC 20005 US
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Contact
KEITH A BARRITT
Other 510(k) Applications for this Contact
Regulation Number
892.1750
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Classification Product Code
JAK
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More FDA Info for this Product Code
Date Received
12/31/2007
Decision Date
04/09/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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