Device Classification Name |
camera, ophthalmic, ac-powered
|
510(k) Number |
K873157 |
Device Name |
OXFORD RETRO-ILLUMINATION CATARACT CAMERA |
Applicant |
HOLOFAX LTD. |
NETHERWOOD ROAD |
ROTHERWAS, HEREFORD |
ENGLAND,
GB
HR2 6JZ
|
|
Applicant Contact |
DAWSON |
Correspondent |
HOLOFAX LTD. |
NETHERWOOD ROAD |
ROTHERWAS, HEREFORD |
ENGLAND,
GB
HR2 6JZ
|
|
Correspondent Contact |
DAWSON |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 08/10/1987 |
Decision Date | 09/30/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|