Data / Medical devices / United States / VHA Office of Advanced Manufacturing - Ft. Lawton
VHA Office of Advanced Manufacturing - Ft. Lawton: FDA-registered device maker in Seattle, WA, United States, 1 510(k) clearance
VHA Office of Advanced Manufacturing - Ft. Lawton is registered with the FDA (registration 3004073926) in Seattle, WA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004073926
- Address
- 4585 Texas Way W, Seattle, WA, United States, 98199
- Owner or operator
- VHA DEAN (10077803)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 5, 2023
- Registered through
- 2026
- Brand names listed
- VA Thumb Splint Class 1 GMP exempt, VHA Radiotherapy Bolus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Block, Beam-Shaping, Radiation Therapy | IXI | 2 | Manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 4, 2022 | K222639 | VHA Radiotherapy Bolus | IXI | Substantially Equivalent | Vha Dean | accessdata.fda.gov |
Compare with other makers
Updated November 4, 2022. 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.