K123184 is an FDA 510(k) clearance for the FINN CHAMBERS AQUA. This device is classified as a Applicator, Absorbent Tipped, Non-sterile (Class I - General Controls, product code KXF).
Submitted by Smartpractice (Phoenix, US). The FDA issued a Cleared decision on December 19, 2012, 70 days after receiving the submission on October 10, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6025.
| 510(k) Number | K123184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2012 |
| Decision Date | December 19, 2012 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KXF — Applicator, Absorbent Tipped, Non-sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6025 |