Device Classification Name |
tonometer, manual
|
510(k) Number |
K132917 |
Device Name |
OCULAR FORCE GAUGE |
Applicant |
OCULAR THERAPEUTIX, INC. |
36 Crosby Dr Ste 101 |
Bedford,
MA
01730
|
|
Applicant Contact |
Eric Ankerud |
Correspondent |
OCULAR THERAPEUTIX, INC. |
36 Crosby Dr Ste 101 |
Bedford,
MA
01730
|
|
Correspondent Contact |
Eric Ankerud |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 09/17/2013 |
Decision Date | 12/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|