FDA device listing
Finn Chambers Aqua
FDA device listing 1251723421 · SMART PRACTICE
Key facts
| Proprietary names | Finn Chambers Aqua |
|---|---|
| Owner/operator | SMART PRACTICE |
| Owner/operator number | 2083595 |
| Premarket submissions | K123184 |
| Product codes | KXF |
| Device names | KXF - Applicator, Absorbent Tipped, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6025 |
| Review panels | General Hospital |
| Registered establishments | SMART PRACTICE |
| Establishment registrations | 2083595 |
| FEI numbers | 2083595 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database