Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K871237 |
Device Name |
SUN CAPSULE I & II SUNTANNING BOOTH |
Applicant |
SUN CAPSULE, INC. |
42 B CHERRY HILL DR. |
DANVERS,
MA
01923
|
|
Applicant Contact |
EUGENE CHARETTE |
Correspondent |
SUN CAPSULE, INC. |
42 B CHERRY HILL DR. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
EUGENE CHARETTE |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 03/27/1987 |
Decision Date | 04/23/1987 |
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
|