Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K980197 |
Device Name |
ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR |
Applicant |
SPECIALTY ULTRAVISION, INC. |
307 ORCHARD CITY DR. |
SUITE 100 |
CAMPBELL,
CA
95008
|
|
Applicant Contact |
IVALEE I COHEN |
Correspondent |
SPECIALTY ULTRAVISION, INC. |
307 ORCHARD CITY DR. |
SUITE 100 |
CAMPBELL,
CA
95008
|
|
Correspondent Contact |
IVALEE I COHEN |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 01/20/1998 |
Decision Date | 08/04/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|