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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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More FDA Info for this Product Code
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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