K143177 is an FDA 510(k) clearance for the KleenGel Dispenser. This device is classified as a Dispenser, Liquid Medication (Class I - General Controls, product code KYX).
Submitted by Kleengel, LLC (Boca Raton, US). The FDA issued a Cleared decision on September 14, 2015, 314 days after receiving the submission on November 4, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6430.
| 510(k) Number | K143177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2014 |
| Decision Date | September 14, 2015 |
| Days to Decision | 314 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KYX — Dispenser, Liquid Medication |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6430 |