Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K862608 |
Device Name |
SPERTILITE PHOTOTHERAPY LAMP |
Applicant |
COOPER-HEWITT ELECTRIC CO. |
ARENT,FOX,KINTNER,PLOTKIN,KAHN |
1050 CONNECTICUT AVENUE, N. W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
P. S REICHERTZ |
Correspondent |
COOPER-HEWITT ELECTRIC CO. |
ARENT,FOX,KINTNER,PLOTKIN,KAHN |
1050 CONNECTICUT AVENUE, N. W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
P. S REICHERTZ |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 07/08/1986 |
Decision Date | 08/06/1986 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|