Submission Details
| 510(k) Number | K171982 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 30, 2017 |
| Decision Date | March 21, 2018 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
DROPLET PEN NEEDLE
Mar 2018
Decision
264d
Days
Class 2
Risk
About This 510(k) Submission
K171982 is an FDA 510(k) clearance for the DROPLET PEN NEEDLE, 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 March 21, 2018, 264 days after receiving the submission on June 30, 2017. 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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