FDA 510(k) Application Details - K060873

Device Classification Name Coil, Magnetic Resonance, Specialty

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510(K) Number K060873
Device Name Coil, Magnetic Resonance, Specialty
Applicant SENTINELLE MEDICAL, INC.
3080 YONGE STREET
SUITE 6020
TORONTO, ONTARIO M4N 3N1 CA
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Contact CAMERON PIRON
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Regulation Number 892.1000

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Classification Product Code MOS
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Date Received 03/30/2006
Decision Date 04/14/2006
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 Y
Expedited Review



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