Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K973967 |
Device Name |
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) |
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 | 10/17/1997 |
Decision Date | 12/08/1997 |
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
|
|
|