Samil Enterprise Co.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Samil Enterprise Co. makes
Samil Enterprise Co. manufactures spectacle frames, which are non-invasive optical devices designed to support eyeglasses and correct vision.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Spectacle Frame Ref K943084
510(k) 510(k)
FDA establishments
- Samil Enterprise Company GYEONGBUK · KR FEI 1000185473
Frequently asked questions
How many devices does Samil Enterprise Co. have in the registry?
The registry currently lists 1 device for Samil Enterprise Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Samil Enterprise Co.'s devices?
Among its 1 most recently registered device, Samil Enterprise Co. has devices listed in FDA 510(k) (1 device).
What risk classes do Samil Enterprise Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Samil Enterprise Co.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Samil Enterprise Co. in the registry?
The most recently registered devices listed for Samil Enterprise Co. include SPECTACLE FRAME.
Which FDA establishments are linked to Samil Enterprise Co.?
1 FDA establishment is linked to Samil Enterprise Co. in the registry; they are listed on the company page.