Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K952165 |
Device Name |
TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS |
Applicant |
RAND SCIENTIFIC CORP. |
4135 NORTHGATE BLVD. |
SUITE 9 |
SACRAMENTO,
CA
95834
|
|
Applicant Contact |
DUANE TRACY |
Correspondent |
RAND SCIENTIFIC CORP. |
4135 NORTHGATE BLVD. |
SUITE 9 |
SACRAMENTO,
CA
95834
|
|
Correspondent Contact |
DUANE TRACY |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 04/03/1995 |
Decision Date | 06/30/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|