Device Classification Name |
lenses, soft contact, daily wear |
|||
---|---|---|---|---|
510(k) Number | K992010 | |||
Device Name | W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) | |||
Applicant |
|
|||
Applicant Contact | carol noble | |||
Correspondent |
|
|||
Correspodent Contact | carol noble | |||
Regulation Number | 886.5925 | |||
Classification Product Code |
|
|||
Date Received | 06/15/1999 | |||
Decision Date | 06/29/1999 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Ophthalmic |
|||
510k Review Panel |
Ophthalmic |
|||
summary |
summary |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |