Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K100388 |
Device Name |
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS |
Applicant |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
547 LIBRARY ST. |
SAN FERNANDO,
CA
91340
|
|
Applicant Contact |
WAYNE GEROW |
Correspondent |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
547 LIBRARY ST. |
SAN FERNANDO,
CA
91340
|
|
Correspondent Contact |
WAYNE GEROW |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 02/16/2010 |
Decision Date | 06/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|