FDA 510(k) Application Details - K181269

Device Classification Name Flowmeter, Blood, Cardiovascular

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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
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Regulation Number 870.2100

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Classification Product Code DPW
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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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