FDA device listing
Hand Teether - BY005 BY006 BY007,Water-fillable Icy Teethers - BY001
FDA device listing 1798722152 · HONG KONG LUTE TECHNOLOGY CO., LIMITED
Key facts
| Proprietary names | Hand Teether - BY005 BY006 BY007,Water-fillable Icy Teethers - BY001 |
|---|---|
| Owner/operator | HONG KONG LUTE TECHNOLOGY CO., LIMITED |
| Owner/operator number | 10088201 |
| Product codes | KKO |
| Device names | KKO - Ring, Teething, Fluid-Filled |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.5550 |
| Review panels | Dental |
| Registered establishments | HONG KONG LUTE TECHNOLOGY CO., LIMITED |
| Establishment registrations | 3027605322 |
| FEI numbers | 3027605322 |
| Establishment operations | Foreign Private Label Distributor, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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