FDA 510(k) Application Details - K061952

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K061952
Device Name Coil, Magnetic Resonance, Specialty
Applicant INVIVO
3545 S.W. 47TH AVE.
GAINESVILLE, FL 32608 US
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Contact THOMAS SCHUBERT
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 07/10/2006
Decision Date 07/28/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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