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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name flowmeter, blood, cardiovascular
510(k) Number K192966
Device Name FlowMet
Applicant
Laser Associated Sciences, Inc.
5171 California Ave., Suite 150
Irvine,  CA  92617
Applicant Contact Sean White
Correspondent
Laser Associated Sciences, Inc.
5171 California Ave., Suite 150
Irvine,  CA  92617
Correspondent Contact Sean White
Regulation Number870.2100
Classification Product Code
DPW  
Date Received10/23/2019
Decision Date 01/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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