The following data is part of a premarket notification filed by Htl-strefa S.a. with the FDA for Dropsafe Safety Pen Needle.
| Device ID | K170988 |
| 510k Number | K170988 |
| Device Name: | DropSafe Safety Pen Needle |
| 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 | 2017-04-03 |
| Decision Date | 2017-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05907996091591 | K170988 | 000 |
| 15907996091581 | K170988 | 000 |
| 40612479239638 | K170988 | 000 |
| 40612479239614 | K170988 | 000 |