Submission Details
| 510(k) Number | K143437 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 01, 2014 |
| Decision Date | June 25, 2015 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Droplet Pen Needles
Jun 2015
Decision
206d
Days
Class 2
Risk
About This 510(k) Submission
K143437 is an FDA 510(k) clearance for the Droplet Pen Needles, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Htl-Strefa S.A (Ozorkow, PL). The FDA issued a Cleared decision on June 25, 2015, 206 days after receiving the submission on December 1, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.
Device Classification
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
Manufacturer
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