| Device Classification Name |
Booth, Sun Tan
|
| 510(k) Number |
K935854 |
| Device Name |
ULTRAVIOLET LAMPS FOR TANNING |
| Applicant |
| Cosmedico Light, Inc. |
| 333 W. Wacker Dr. |
| Suite 2600 |
|
Chicago,
IL
60606 -1218
|
|
| Applicant Contact |
THOMAS J MULDOON |
| Correspondent |
| Cosmedico Light, Inc. |
| 333 W. Wacker Dr. |
| Suite 2600 |
|
Chicago,
IL
60606 -1218
|
|
| Correspondent Contact |
THOMAS J MULDOON |
| Regulation Number | 878.4635 |
| Classification Product Code |
|
| Date Received | 12/08/1993 |
| Decision Date | 01/24/1994 |
| 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
|
|
|