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FDA 510(k) Application Details - K042935
Device Classification Name
System, Tomography, Computed, Emission
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510(K) Number
K042935
Device Name
System, Tomography, Computed, Emission
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND, OH 44143 US
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Contact
RAE ANN FARROW
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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
10/25/2004
Decision Date
11/09/2004
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
Y
Expedited Review
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