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FDA 510(k) Application Details - K071534
Device Classification Name
Coil, Magnetic Resonance, Specialty
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510(K) Number
K071534
Device Name
Coil, Magnetic Resonance, Specialty
Applicant
CONFIRMA, INC.
11040 MAIN STREET
SUITE 100
BELLEVUE, WA 98004 US
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Contact
PATRICIA A MILBANK
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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
06/05/2007
Decision Date
07/09/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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