Device Classification Name |
Set, Lens, Trial, Ophthalmic
|
510(k) Number |
K951437 |
Device Name |
OTI MODEL TLS-60 |
Applicant |
OTI MEDICAL LLC. |
530 BERCUT DR. |
SUITER J |
SACRAMENTO,
CA
95814
|
|
Applicant Contact |
WILL MARKLE |
Correspondent |
OTI MEDICAL LLC. |
530 BERCUT DR. |
SUITER J |
SACRAMENTO,
CA
95814
|
|
Correspondent Contact |
WILL MARKLE |
Regulation Number | 886.1405
|
Classification Product Code |
|
Date Received | 03/27/1995 |
Decision Date | 04/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|