Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K011914 |
Device Name |
HYDRO2, HS-75 |
Applicant |
INNOVISION, INC. |
3125 SOUTH 61ST AVE. |
OMAHA,
NE
68106 -3675
|
|
Applicant Contact |
DON M WOODFORD |
Correspondent |
INNOVISION, INC. |
3125 SOUTH 61ST AVE. |
OMAHA,
NE
68106 -3675
|
|
Correspondent Contact |
DON M WOODFORD |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 06/19/2001 |
Decision Date | 07/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|