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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K181895
Device Name Kurin PIV Blood Collection Set with High Pressure
Applicant
Kurin, Inc.
10840 Thornmint Rd.,
Suite 111
San Diego,  CA  92127
Applicant Contact Bob Rogers
Correspondent
Independent Consultant
892 Summer Moon Rd.
San Marcos,  CA  92078
Correspondent Contact Neal Hartman
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FPA  
Date Received07/16/2018
Decision Date 01/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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