Device Classification Name |
Keratoscope, Ac-Powered
|
510(k) Number |
K853668 |
Device Name |
ORC ORACLE |
Applicant |
OPTICAL RADIATION CORP. |
1300 OPTICAL DR. |
AZUSA,
CA
91702
|
|
Applicant Contact |
CHARMAINE HENDERSON |
Correspondent |
OPTICAL RADIATION CORP. |
1300 OPTICAL DR. |
AZUSA,
CA
91702
|
|
Correspondent Contact |
CHARMAINE HENDERSON |
Regulation Number | 886.1350
|
Classification Product Code |
|
Date Received | 09/03/1985 |
Decision Date | 10/15/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|