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FDA 510(k) Application Details - K050815
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K050815
Device Name
System, Tomography, Computed, Emission
Applicant
ULTRASPECT LTD.
BULLDING 30 MATAM
HAFIA 31905 IL
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Contact
DAN LAOR
Other 510(k) Applications for this Contact
Regulation Number
892.1200
More FDA Info for this Regulation Number
Classification Product Code
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2005
Decision Date
04/26/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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