Clearance Summary
Droplet Pen Needle 34G received FDA 510(k) clearance under submission number K192082, sponsored by Htl-Strefa S.A. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2020-04-21.
- Submission: K192082
- Applicant / Sponsor: Htl-Strefa S.A
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2020-04-21
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.