Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K130519 |
Device Name |
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS |
Applicant |
PHILIPS LIGHTING COMPANY |
3861 SOUTH 9TH STREET |
SALINA,
KS
67401
|
|
Applicant Contact |
JAMES R CYRE |
Correspondent |
PHILIPS LIGHTING COMPANY |
3861 SOUTH 9TH STREET |
SALINA,
KS
67401
|
|
Correspondent Contact |
JAMES R CYRE |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 02/27/2013 |
Decision Date | 12/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|