FDA 510(k) Application Details - K031095

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K031095
Device Name Coil, Magnetic Resonance, Specialty
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND, OH 44143 US
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Contact DUANE C PRASCHAN
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 04/07/2003
Decision Date 06/20/2003
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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