FDA 510(k) Application Details - K051763

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K051763
Device Name Coil, Magnetic Resonance, Specialty
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 MICHELLE DR.
P.O. BOX 2068
TUSTIN, CA 92781-2068 US
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Contact MICHAELA MAHL
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 06/30/2005
Decision Date 07/14/2005
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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