Kookje Apis Industrial Co.
South KoreaFDA 510(k) applicant, unverified
- Devices
- 1
What Kookje Apis Industrial Co. makes
Kookje Apis Industrial Co. manufactures spectacle frames, which are designed for use in corrective eyewear. These products are intended to provide structural support and fit for eyeglass lenses, catering to various prescription needs and aesthetic preferences.
The company’s spectacle frames are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are regulated in the United States, where the manufacturer is based.
Catalogue
Frame, Spectacle Ref K945450
510(k) 510(k)
Frequently asked questions
How many devices does Kookje Apis Industrial Co. have in the registry?
The registry currently lists 1 device for Kookje Apis Industrial Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kookje Apis Industrial Co.'s devices?
Among its 1 most recently registered device, Kookje Apis Industrial Co. has devices listed in FDA 510(k) (1 device).
What risk classes do Kookje Apis Industrial Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Kookje Apis Industrial Co.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Kookje Apis Industrial Co. in the registry?
The most recently registered devices listed for Kookje Apis Industrial Co. include FRAME, SPECTACLE.