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.
| Device ID | K181895 |
| 510k Number | K181895 |
| Device Name: | Kurin PIV Blood Collection Set With High Pressure |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Kurin, Inc 10840 Thornmint Road, Suite 111 San Diego, CA 92127 |
| Contact | Bob Rogers |
| Correspondent | Neal Hartman Independent Consultant 892 Summer Moon Road San Marcos, CA 92078 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-16 |
| Decision Date | 2019-01-18 |
| Summary: | summary |