The following data is part of a premarket notification filed by Scandinavian Health Limited with the FDA for Push-on Needle 30gx8mm.
| Device ID | K120191 |
| 510k Number | K120191 |
| Device Name: | PUSH-ON NEEDLE 30GX8MM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SCANDINAVIAN HEALTH LIMITED NO. 136, KUO SHENG 2ND STREET Taoyuan City, TW 33060 |
| Contact | Sharlin Yeh |
| Correspondent | Sharlin Yeh SCANDINAVIAN HEALTH LIMITED NO. 136, KUO SHENG 2ND STREET Taoyuan City, TW 33060 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-05-23 |
| Summary: | summary |