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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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CAMERON PIRON
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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
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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