The following data is part of a premarket notification filed by Htl-strefa S.a with the FDA for Droplet Pen Needle 34g.
| Device ID | K192082 |
| 510k Number | K192082 |
| Device Name: | Droplet Pen Needle 34G |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | HTL-Strefa S.A Adamowek 7 Ozorkow, PL 95-035 |
| Contact | Aleksandra Prazmowska-wilanowska |
| Correspondent | Aleksandra Prazmowska-wilanowska HTL-Strefa S.A Adamowek 7 Ozorkow, PL 95-035 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-02 |
| Decision Date | 2020-04-21 |