Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K981252 |
Device Name |
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) |
Applicant |
ALDEN OPTICAL LABS., INC. |
623 GLACIER DR. |
GRAND JUNCTION,
CO
81503
|
|
Applicant Contact |
MARTIN DALSING |
Correspondent |
ALDEN OPTICAL LABS., INC. |
623 GLACIER DR. |
GRAND JUNCTION,
CO
81503
|
|
Correspondent Contact |
MARTIN DALSING |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 04/06/1998 |
Decision Date | 06/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|