510(k) K022989
- Device
- RADLITE TISSUE RETRACTOR SYSTEM
- Applicant
- GENZYME BIOSURGERY
- 510(k) number
- K022989
- Product code
- FSW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-25
- Date received
- 2002-09-09
- Regulation
- 878.4580
- Classification name
- Light, Surgical, Endoscopic
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN K SYLVIA
- Address
- 600 Airport Rd. Fall River MA US 02720 02720
FDA Registration Numbers#
- 3023809973
- 3021562244
- 3010393950
- 9680718
- 3015972835
- 3010041511
- 1035968
- 3011137372
- 3012777736
- 3022320321
Source Documents#
Other 510(k) Records For Product Code FSW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K870898 | ULTRA-LUX LIGHT SOURCE | Medline Industries, Inc. | 1987-03-18 |
Legacy Summary#
summary
FDA Review#
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