Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K854111 |
Device Name |
EXPRESS TAN SUN CANOPY |
Applicant |
SUNMAKER TANNING SYSTEMS, LTD. |
3 DEPOT ST. |
P.O. BOX 230 |
HUDSON FALLS,
NY
12839
|
|
Applicant Contact |
LINDA A LIBERTY |
Correspondent |
SUNMAKER TANNING SYSTEMS, LTD. |
3 DEPOT ST. |
P.O. BOX 230 |
HUDSON FALLS,
NY
12839
|
|
Correspondent Contact |
LINDA A LIBERTY |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 10/08/1985 |
Decision Date | 11/08/1985 |
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
|
|
|