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FDA 510(k) Application Details - K123095
Device Classification Name
Transducer, Blood-Pressure, Extravascular
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510(K) Number
K123095
Device Name
Transducer, Blood-Pressure, Extravascular
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact
MATT CLAUSEN
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Regulation Number
870.2850
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Classification Product Code
DRS
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More FDA Info for this Product Code
Date Received
10/02/2012
Decision Date
05/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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