FDA 510(k) Application Details - K111251

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K111251
Device Name Coil, Magnetic Resonance, Specialty
Applicant TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
2441 MICHELLE DR
TUSTIN, CA 92780 US
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Contact PAUL BIGGINS
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 05/04/2011
Decision Date 05/27/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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