The following data is part of a premarket notification filed by Htl-strefa S.a. with the FDA for Droplet Pen Needle 30g & 33g.
| Device ID | K202340 |
| 510k Number | K202340 |
| Device Name: | Droplet Pen Needle 30G & 33G |
| 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 | 2020-08-17 |
| Decision Date | 2020-10-15 |