Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K873430 |
Device Name |
FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12 |
Applicant |
KLAFS SUNLIGHT CORP. |
525 WEST UNIVERSITY DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
ROLF SPIES |
Correspondent |
KLAFS SUNLIGHT CORP. |
525 WEST UNIVERSITY DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
ROLF SPIES |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 08/26/1987 |
Decision Date | 09/25/1987 |
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
|