Device Classification Name |
transilluminator, ac-powered
|
510(k) Number |
K913273 |
Device Name |
DROLITE(TM) LIGHT SOURCE |
Applicant |
VISION MEDICAL, INC. |
820 OPTIMO AVE. |
FREMONT,
CA
94539
|
|
Applicant Contact |
JOHNNY L YEE |
Correspondent |
VISION MEDICAL, INC. |
820 OPTIMO AVE. |
FREMONT,
CA
94539
|
|
Correspondent Contact |
JOHNNY L YEE |
Regulation Number | 886.1945
|
Classification Product Code |
|
Date Received | 07/23/1991 |
Decision Date | 12/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|