Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K900649 |
Device Name |
FLUORESCENT T12 UVA LAMP |
Applicant |
LIGHT SOURCES, INC. |
P.O. BOX 569 |
410 MAIN ST. |
ANSONIA,
CT
06401
|
|
Applicant Contact |
GENE CZAKO |
Correspondent |
LIGHT SOURCES, INC. |
P.O. BOX 569 |
410 MAIN ST. |
ANSONIA,
CT
06401
|
|
Correspondent Contact |
GENE CZAKO |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 02/09/1990 |
Decision Date | 03/28/1990 |
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
|
|
|