CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
FDA 510(k) clearance K934337 · decided 1993-11-18
Clearance details
- K-number
- K934337
- Device name
- CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
- Applicant
- Cuda Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-07
- Decision date
- 1993-11-18
- Days to decision
- 72 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
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cuda Products Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| ILLUMINATOR IV MINOR SURGERY LIGHT (K922279) | Medical Illumination, Inc. | 1992-09-02 |
| LM-300TWIN (K913135) | Leisegang Medical, Inc. | 1991-09-18 |
| MEDICAL DYNAMICS LIGHT SOURCE (K894319) | Medical Dynamics, Inc. | 1989-10-03 |
| ULTRA-LUX LIGHT SOURCE (K870898) | Medline Industries, Inc. | 1987-03-18 |
Recalls involving this device
No recalls on record reference this clearance.