Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K042242 |
Device Name |
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES |
Applicant |
ALDEN OPTICAL LABS., INC. |
13295 BROADWAY |
ALDEN,
NY
14004
|
|
Applicant Contact |
CHARLES H CREIGHTON |
Correspondent |
ALDEN OPTICAL LABS., INC. |
13295 BROADWAY |
ALDEN,
NY
14004
|
|
Correspondent Contact |
CHARLES H CREIGHTON |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 08/19/2004 |
Decision Date | 09/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|