FDA 510(k) Application Details - K073131

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K073131
Device Name Coil, Magnetic Resonance, Specialty
Applicant MICROMRI, INC.
1429 WALNUT ST., SUITE 1102
PHILADELPHIA, PA 19102 US
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Contact Hrishikesh Gadagkar
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 11/06/2007
Decision Date 01/18/2008
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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