FDA 510(k) Application Details - K001944

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K001944
Device Name Coil, Magnetic Resonance, Specialty
Applicant MRI DEVICES CORP.
1515 PARAMOUNT DR.
WAUKESHA, WI 53186 US
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Contact TOM SCHUBERT
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 06/26/2000
Decision Date 08/14/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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