510(k) K833229
- Device
- Sun Bed By Verre Et Quartz Uva-france
- Applicant
- H & M DOUGLAS ENTERPRISES, INC.
- 510(k) number
- K833229
- Product code
- FTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-27
- Date received
- 1983-08-24
- Regulation
- 886.4445
- Classification name
- Locator, Magnetic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8030607
- 1421101
- 1836161
- 3010041511
- 3011137372
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FTZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830468 | MODEL 200 | Western Laboratories Corp. | 1983-04-12 |