Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K042382 |
Device Name |
DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD |
Applicant |
MED-GENERAL TECHNOLOGIES LLC |
1016 COLLIER CENTER WAY |
SUITE 102 |
NAPLES,
FL
34110
|
|
Applicant Contact |
PAUL MCCREIGHT |
Correspondent |
MED-GENERAL TECHNOLOGIES LLC |
1016 COLLIER CENTER WAY |
SUITE 102 |
NAPLES,
FL
34110
|
|
Correspondent Contact |
PAUL MCCREIGHT |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 09/01/2004 |
Decision Date | 11/30/2004 |
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
|