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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 K191388
Device Name FloPatch (FP110)
Applicant
Flosonics Medical (R/A 1929803 Ontario Corp.)
204-73 Elm St.
Sudbury,  CA P3C 1R7
Applicant Contact Joe Eibl
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number870.2100
Classification Product Code
DPW  
Date Received05/24/2019
Decision Date 06/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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