Device Classification Name |
Transilluminator, Battery-Powered
|
510(k) Number |
K912747 |
Device Name |
LULMITEX NEONATAL TRANSILLUMINATOR |
Applicant |
LUMITEX, INC. |
11941 ABBEY ROAD, BLDG. H |
CLEVELAND,
OH
44133
|
|
Applicant Contact |
JEFFERY R PARKER |
Correspondent |
LUMITEX, INC. |
11941 ABBEY ROAD, BLDG. H |
CLEVELAND,
OH
44133
|
|
Correspondent Contact |
JEFFERY R PARKER |
Regulation Number | 886.1945
|
Classification Product Code |
|
Date Received | 06/21/1991 |
Decision Date | 12/24/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|