MEDICAL DYNAMICS LIGHT SOURCE
FDA 510(k) clearance K894319 · decided 1989-10-03
Clearance details
- K-number
- K894319
- Device name
- MEDICAL DYNAMICS LIGHT SOURCE
- Applicant
- Medical Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-14
- Decision date
- 1989-10-03
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- FSW
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RADLITE TISSUE RETRACTOR SYSTEM (K022989) | Genzyme Biosurgery | 2002-11-25 |
| XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (K013511) | Aculux, Inc. | 2002-02-01 |
| MEDICAM XENON LIGHT SOURCE (K943342) | M.P. Video, Inc. | 1994-10-17 |
| CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (K934337) | Cuda Products Co. | 1993-11-18 |
| ILLUMINATOR IV MINOR SURGERY LIGHT (K922279) | Medical Illumination, Inc. | 1992-09-02 |
| LM-300TWIN (K913135) | Leisegang Medical, Inc. | 1991-09-18 |
| ULTRA-LUX LIGHT SOURCE (K870898) | Medline Industries, Inc. | 1987-03-18 |
Recalls involving this device
No recalls on record reference this clearance.