The following data is part of a premarket notification filed by Htl-strefa S.a with the FDA for Droplet Pen Needle 34g.
Device ID | K192082 |
510k Number | K192082 |
Device Name: | Droplet Pen Needle 34G |
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 | 2019-08-02 |
Decision Date | 2020-04-21 |