Plastikon Industries
United Statesfrom the FDA registration address FDA establishment FEI 3009974297
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
What Plastikon Industries makes
Plastikon Industries manufactures the ICU Health Surgical Mask, a single-use barrier device designed for healthcare settings to reduce the risk of infection during surgical procedures.
The company’s portfolio is regulated under FDA’s Class II device classification, with the ICU Health Surgical Mask authorised via the 510(k) pathway. The product is listed in the FDA’s 510(k) database.
Catalogue
ICU Health Surgical Mask Ref K203064
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009974297
- Address
- 687 Sandoval Way, Hayward, CA, 94544
Frequently asked questions
How many devices does Plastikon Industries have in the registry?
The registry currently lists 1 device for Plastikon Industries. Devices recorded under merged duplicate company entries are counted once.
Which registries list Plastikon Industries's devices?
Among its 1 most recently registered device, Plastikon Industries has devices listed in FDA 510(k) (1 device).
What risk classes do Plastikon Industries's devices fall under?
Among its 1 most recently registered device, the classes recorded for Plastikon Industries's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Plastikon Industries in the registry?
The most recently registered devices listed for Plastikon Industries include ICU Health Surgical Mask.