| Device Classification Name |
Light, Ultraviolet, Dermatological
|
| 510(k) Number |
K860566 |
| Device Name |
NORDIC SUN 24 LAMP TANNING BED |
| Applicant |
| NORDIC SUN CORPORATION OF AMERICA |
| 2770 SUMMER ST. |
|
STAMFORD,
CT
06905
|
|
| Applicant Contact |
ADRIAN WERNER |
| Correspondent |
| NORDIC SUN CORPORATION OF AMERICA |
| 2770 SUMMER ST. |
|
STAMFORD,
CT
06905
|
|
| Correspondent Contact |
ADRIAN WERNER |
| Regulation Number | 878.4630 |
| Classification Product Code |
|
| Date Received | 02/14/1986 |
| Decision Date | 03/05/1986 |
| 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
|