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FDA 510(k) Application Details - K082354
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K082354
Device Name
System, Tomography, Computed, Emission
Applicant
NAVISCAN PET SYSTEMS
11180 ROSELLE ST, STE 100
SAN DIEGO, CA 92121 US
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Contact
HEATHER JALISI
Other 510(k) Applications for this Contact
Regulation Number
892.1200
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Classification Product Code
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/15/2008
Decision Date
11/18/2008
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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