Device Classification Name |
Set, Lens, Trial, Ophthalmic
|
510(k) Number |
K930195 |
Device Name |
OPHTHALMIC TRIAL LENSES |
Applicant |
OPTIMARK ACCESSORIES AND INSTRUMENTS |
P.O. BOX 14115 |
SEATTLE,
WA
98104
|
|
Applicant Contact |
CHRISTINE K MARK |
Correspondent |
OPTIMARK ACCESSORIES AND INSTRUMENTS |
P.O. BOX 14115 |
SEATTLE,
WA
98104
|
|
Correspondent Contact |
CHRISTINE K MARK |
Regulation Number | 886.1405
|
Classification Product Code |
|
Date Received | 01/14/1993 |
Decision Date | 01/06/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|