Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K020608 |
Device Name |
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) |
Applicant |
POLY VUE TECHNOLGIES, INC. |
623 GLACIER DR. |
GRAND JUNCTION,
CO
81503
|
|
Applicant Contact |
DEANNA WERBER |
Correspondent |
POLY VUE TECHNOLGIES, INC. |
623 GLACIER DR. |
GRAND JUNCTION,
CO
81503
|
|
Correspondent Contact |
DEANNA WERBER |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 02/25/2002 |
Decision Date | 05/16/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|