FDA 510(k) Application Details - K090267

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K090267
Device Name Coil, Magnetic Resonance, Specialty
Applicant MIDWEST R.F. LLC.
1015 WALNUT RIDGE DRIVE
PO BOX 348
HARTLAND, WI 53029 US
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Contact DAVID M PETERSON
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 02/03/2009
Decision Date 03/16/2009
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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