Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K011316 |
Device Name |
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T |
Applicant |
AMERICAN CONTACT LENS, INC. |
623 GLACIER DR. |
GRAND JUNCTION,
CO
81503
|
|
Applicant Contact |
MARTIN DALSING |
Correspondent |
AMERICAN CONTACT LENS, INC. |
623 GLACIER DR. |
GRAND JUNCTION,
CO
81503
|
|
Correspondent Contact |
MARTIN DALSING |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 04/30/2001 |
Decision Date | 06/13/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|