| Device Classification Name |
Light, Ultraviolet, Dermatological
|
| 510(k) Number |
K885184 |
| Device Name |
SHAW SUN SYSTEMS MODEL 2400 |
| Applicant |
| Shaw Sun Systems |
| Rt. 2 Box 216 |
|
Brookline,
MO
65619
|
|
| Applicant Contact |
ROCKY L HILBURN |
| Correspondent |
| Shaw Sun Systems |
| Rt. 2 Box 216 |
|
Brookline,
MO
65619
|
|
| Correspondent Contact |
ROCKY L HILBURN |
| Regulation Number | 878.4630 |
| Classification Product Code |
|
| Date Received | 12/13/1988 |
| Decision Date | 01/09/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|