Device Classification Name |
refractometer, ophthalmic
|
510(k) Number |
K882287 |
Device Name |
CANON AUTOREFRACTOMETER R-20 |
Applicant |
CANON U.S.A., INC. |
ONE JERICHO PLAZA |
JERICHO,
NY
11753 -1000
|
|
Applicant Contact |
TAMADA |
Correspondent |
CANON U.S.A., INC. |
ONE JERICHO PLAZA |
JERICHO,
NY
11753 -1000
|
|
Correspondent Contact |
TAMADA |
Regulation Number | 886.1760
|
Classification Product Code |
|
Date Received | 06/01/1988 |
Decision Date | 07/01/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|