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FDA 510(k) Application Details - K030505
Device Classification Name
Flowmeter, Blood, Cardiovascular
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510(K) Number
K030505
Device Name
Flowmeter, Blood, Cardiovascular
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON, MD 21921 US
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Contact
GARRY A COURTNEY
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Regulation Number
870.2100
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Classification Product Code
DPW
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More FDA Info for this Product Code
Date Received
02/19/2003
Decision Date
05/14/2003
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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