Kurin PIV Blood Collection Set With High Pressure

Tubes, Vials, Systems, Serum Separators, Blood Collection

Kurin, Inc

The following data is part of a premarket notification filed by Kurin, Inc with the FDA for Kurin Piv Blood Collection Set With High Pressure.

Pre-market Notification Details

Device IDK181895
510k NumberK181895
Device Name:Kurin PIV Blood Collection Set With High Pressure
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Kurin, Inc 10840 Thornmint Road, Suite 111 San Diego,  CA  92127
ContactBob Rogers
CorrespondentNeal Hartman
Independent Consultant 892 Summer Moon Road San Marcos,  CA  92078
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-16
Decision Date2019-01-18
Summary:summary

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