FDA 510(k) Application Details - K111259

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K111259
Device Name Coil, Magnetic Resonance, Specialty
Applicant MIDWEST RF, LLC
P.O. BOX 348
1015 WALNUT RIDGE DRIVE
HARTLAND, WI 53029 US
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Contact HELMUT KEIDI
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 05/04/2011
Decision Date 07/05/2011
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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