FDA 510(k) Application Details - K110487

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K110487
Device Name Coil, Magnetic Resonance, Specialty
Applicant LBDS HOLDING COMPANY
6440 SKY POINTE DR
SUITE 140
LAS VEGAS, NV 89131 US
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Contact RICHARD BRYANT
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 02/22/2011
Decision Date 04/19/2011
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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