FDA 510(k) Application Details - K012728

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K012728
Device Name Coil, Magnetic Resonance, Specialty
Applicant BIOSOUND ESAOTE, INC.
8000 CASTLEWAY DR.
INDIANAPOLIS, IN 46250 US
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Contact COLLEEN HITTLE
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 08/15/2001
Decision Date 08/29/2001
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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