Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K872648 |
Device Name |
SOLAR GOLD UVA SUN TANNING BED |
Applicant |
AN-MAR INTERNATIONAL, LTD. |
345 EAST BEINORIS DR. |
WOOD DALE,
IL
60191
|
|
Applicant Contact |
ANDRZEJ BOBEL |
Correspondent |
AN-MAR INTERNATIONAL, LTD. |
345 EAST BEINORIS DR. |
WOOD DALE,
IL
60191
|
|
Correspondent Contact |
ANDRZEJ BOBEL |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 07/07/1987 |
Decision Date | 08/04/1987 |
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
|