Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K935572 |
Device Name |
SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT |
Applicant |
SOLARC SYSTEMS, INC. |
12 PARKER COURT |
BARRIE, ONTARIO, CANADA,
CA
L4N 2A6
|
|
Applicant Contact |
BRUCE ELLIOTT |
Correspondent |
SOLARC SYSTEMS, INC. |
12 PARKER COURT |
BARRIE, ONTARIO, CANADA,
CA
L4N 2A6
|
|
Correspondent Contact |
BRUCE ELLIOTT |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 11/18/1993 |
Decision Date | 03/07/1994 |
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
|
|
|