FDA 510(k) Application Details - K071534

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K071534
Device Name Coil, Magnetic Resonance, Specialty
Applicant CONFIRMA, INC.
11040 MAIN STREET
SUITE 100
BELLEVUE, WA 98004 US
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Contact PATRICIA A MILBANK
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 06/05/2007
Decision Date 07/09/2007
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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