The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Hlic Needle-less Valve.
| Device ID | K120548 |
| 510k Number | K120548 |
| Device Name: | HLIC NEEDLE-LESS VALVE |
| Classification | Set, Administration, Intravascular |
| Applicant | HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville, UT 84014 |
| Contact | Nola Benstog |
| Correspondent | Nola Benstog HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville, UT 84014 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-23 |
| Decision Date | 2012-05-04 |
| Summary: | summary |