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FDA 510(k) Application Details - K102033
Device Classification Name
Transducer, Blood-Pressure, Extravascular
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510(K) Number
K102033
Device Name
Transducer, Blood-Pressure, Extravascular
Applicant
B. BRAUN MELSUNGEN AG
901 MARCON BLVD
ALLENTOWN, PA 18109 US
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Contact
LISA GIAQUINTO
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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
07/19/2010
Decision Date
04/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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