Data / Medical devices / Netherlands / Frame Holland BV
Frame Holland BV: FDA-registered device maker in Burgerveen Noord-Holland, Netherlands, 1 510(k) clearance
Frame Holland BV is registered with the FDA (registration 3006056331) in Burgerveen Noord-Holland, Netherlands. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 5, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006056331
- Address
- Oude Venneperweg 23, Burgerveen Noord-Holland, Netherlands, 2154 MG
- Owner or operator
- Frame Holland BV (10036241)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 25, 2011
- Registered through
- 2026
- Brand names listed
- Eyetem, Goliath, Preciosa, SEE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Frame, Spectacle | HQZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 1993 | K926065 | EYEGLASS FRAMES AND SUNGLASSES | HQY | Substantially Equivalent | Palm Optical Co., Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 5, 1993. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.