Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K861963 |
Device Name |
ULTRALITE HF1236 HAND AND FOOT SYSTEM |
Applicant |
ULTRALITE |
390 FARMER CT. |
LAWRENCEVILLE,
GA
30245
|
|
Applicant Contact |
WILLIAM C MCMILLAN |
Correspondent |
ULTRALITE |
390 FARMER CT. |
LAWRENCEVILLE,
GA
30245
|
|
Correspondent Contact |
WILLIAM C MCMILLAN |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 05/20/1986 |
Decision Date | 06/25/1986 |
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
|