The following data is part of a premarket notification filed by Htl Strefa Sa with the FDA for Dropsafe Safety Pen Needles.
| Device ID | K211716 |
| 510k Number | K211716 |
| Device Name: | DropSafe Safety Pen Needles |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | HTL STREFA SA ul. Adamówek 7 Ozorków, PL 95-035 |
| Contact | Justyna Zemigala |
| Correspondent | Justyna Zemigala HTL STREFA SA ul. Adamówek 7 Ozorków, 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 | 2021-06-03 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 85907996098589 | K211716 | 000 |
| 15903999601796 | K211716 | 000 |