510(k) K870898
- Device
- Ultra-lux Light Source
- Applicant
- MEDLINE INDUSTRIES, INC.
- 510(k) number
- K870898
- Product code
- FSW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-03-18
- Date received
- 1987-03-05
- Regulation
- 878.4580
- Classification name
- Light, Surgical, Endoscopic
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JO BREHM
- Address
- 99 Inverness Dr. E. Englewood CO US 80112 80112
FDA Registration Numbers#
- 3023809973
- 3010041511
- 3012777736
- 9680718
- 3011137372
- 3022320321
- 1035968
- 3021562244
- 3010393950
- 3015972835
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FSW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022989 | RADLITE TISSUE RETRACTOR SYSTEM | Genzyme Biosurgery | 2002-11-25 |
| K013511 | XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) | Aculux, Inc. | 2002-02-01 |
| K943342 | MEDICAM XENON LIGHT SOURCE | M.P. Video, Inc. | 1994-10-17 |
| K934337 | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | Cuda Products Co. | 1993-11-18 |
| K922279 | ILLUMINATOR IV MINOR SURGERY LIGHT | Medical Illumination, Inc. | 1992-09-02 |
| K913135 | LM-300TWIN | Leisegang Medical, Inc. | 1991-09-18 |
| K894319 | MEDICAL DYNAMICS LIGHT SOURCE | Medical Dynamics, Inc. | 1989-10-03 |