FDA 510(k) Application Details - K062556

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K062556
Device Name Coil, Magnetic Resonance, Specialty
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 SUMMIT COMMERCE PARK
TWINSBURG, OH 44087 US
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Contact DOUG THISTLEWAITE
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 08/30/2006
Decision Date 10/05/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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