The following data is part of a premarket notification filed by Htl-strefa S.a. with the FDA for Droplet Pen Needles.
| Device ID | K143437 |
| 510k Number | K143437 |
| Device Name: | Droplet Pen Needles |
| 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 | 2014-12-01 |
| Decision Date | 2015-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50096295129132 | K143437 | 000 |
| 10021292009042 | K143437 | 000 |
| 10021292009073 | K143437 | 000 |
| 10021292009035 | K143437 | 000 |
| 10021292009059 | K143437 | 000 |
| 10021292009066 | K143437 | 000 |
| 50096295129095 | K143437 | 000 |
| 50096295129101 | K143437 | 000 |
| 50096295129118 | K143437 | 000 |
| 50096295129125 | K143437 | 000 |
| 10021292010314 | K143437 | 000 |