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FDA 510(k) Application Details - K080120
Device Classification Name
Coil, Magnetic Resonance, Specialty
More FDA Info for this Device
510(K) Number
K080120
Device Name
Coil, Magnetic Resonance, Specialty
Applicant
PHILIPS MEDICAL SYSTEMS MR FINLAND
595 MINER ROAD
CLEVELAND, OH 44143 US
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Contact
CATHERINE CONNELL
Other 510(k) Applications for this Contact
Regulation Number
892.1000
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Classification Product Code
MOS
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More FDA Info for this Product Code
Date Received
01/17/2008
Decision Date
03/10/2008
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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