FDA 510(k) Application Details - K023929

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K023929
Device Name Coil, Magnetic Resonance, Specialty
Applicant ADVANCED IMAGING RESEARCH, INC.
4700 LAKESIDE AVE.
SUITE 400
CLEVELAND, OH 44114-3834 US
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Contact RAVI SRINIVASAN
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 11/25/2002
Decision Date 02/21/2003
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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