The following data is part of a premarket notification filed by Htl-strefa S.a. with the FDA for Droplet Pen Needle.
| Device ID | K171982 |
| 510k Number | K171982 |
| Device Name: | DROPLET 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 | 2017-06-30 |
| Decision Date | 2018-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15907996097101 | K171982 | 000 |
| 10015482234321 | K171982 | 000 |
| 10015482235311 | K171982 | 000 |
| 10015482236325 | K171982 | 000 |
| 10015482238312 | K171982 | 000 |
| 85907996099388 | K171982 | 000 |
| 85907996099395 | K171982 | 000 |
| 15907996099402 | K171982 | 000 |
| 15907996099419 | K171982 | 000 |
| 50096295138738 | K171982 | 000 |
| 50096295138745 | K171982 | 000 |
| 50096295138752 | K171982 | 000 |
| 50096295138769 | K171982 | 000 |
| 50096295138776 | K171982 | 000 |
| 15907996092991 | K171982 | 000 |
| 15907996097088 | K171982 | 000 |
| 15907996097095 | K171982 | 000 |
| 10015482232297 | K171982 | 000 |