Device Classification Name |
tonometer, manual
|
510(k) Number |
K964312 |
Device Name |
MENTOR TONO-PEN 3 |
Applicant |
MENTOR OPHTHALMICS, INC. |
3000 LONGWATER DR. |
NORWELL,
MA
02061 -1672
|
|
Applicant Contact |
DAVID M DOWNEY |
Correspondent |
MENTOR OPHTHALMICS, INC. |
3000 LONGWATER DR. |
NORWELL,
MA
02061 -1672
|
|
Correspondent Contact |
DAVID M DOWNEY |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 10/29/1996 |
Decision Date | 11/26/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|