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FDA 510(k) Application Details - K181269
Device Classification Name
Flowmeter, Blood, Cardiovascular
More FDA Info for this Device
510(K) Number
K181269
Device Name
Flowmeter, Blood, Cardiovascular
Applicant
Rfpi
1800 N Greene Street, Suite K
Greenville, NC 27834 US
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Contact
Jeffery Basham
Other 510(k) Applications for this Contact
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
05/14/2018
Decision Date
12/14/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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