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 Road, Suite 111 |
San Diego,
CA
92127
|
|
Applicant Contact |
Bob Rogers |
Correspondent |
Independent Consultant |
892 Summer Moon Road |
San Marcos,
CA
92078
|
|
Correspondent Contact |
Neal Hartman |
Regulation Number | 862.1675
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/16/2018 |
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
|
|
|