Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K803264 |
Device Name |
SUNLAMP |
Applicant |
AM LABS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AM LABS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 12/24/1980 |
Decision Date | 06/02/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|