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FDA 510(k) Application Details - K102433
Device Classification Name
Flowmeter, Blood, Cardiovascular
More FDA Info for this Device
510(K) Number
K102433
Device Name
Flowmeter, Blood, Cardiovascular
Applicant
MOOR INSTRUMENTS LTD.
MILLWEY
AXMINSTER, DEVON EX135HU GB
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Contact
XIABING HUANG
Other 510(k) Applications for this Contact
Regulation Number
870.2100
More FDA Info for this Regulation Number
Classification Product Code
DPW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/26/2010
Decision Date
11/18/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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