FDA 510(k) Application Details - K050621

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K050621
Device Name Coil, Magnetic Resonance, Specialty
Applicant MRI DEVICES CORPORATION
N27W23676 PAUL RD
PEWAUKEE, WI 53072 US
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Contact THOMAS SCHUBERT
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 03/10/2005
Decision Date 04/07/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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