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FDA 510(k) Application Details - K040616
Device Classification Name
System, Tomography, Computed, Emission
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510(K) Number
K040616
Device Name
System, Tomography, Computed, Emission
Applicant
DANISH DIAGNOSTIC DEVELOPMENT A/S
DR. NEERGAARDSVEJ 5F
HORSHOLM DK
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Contact
NIELS SORENSEN
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Regulation Number
892.1200
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Classification Product Code
KPS
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More FDA Info for this Product Code
Date Received
03/09/2004
Decision Date
03/24/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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