Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K020006 |
Device Name |
DYNA INTRA-LIMBAL LENS |
Applicant |
LENS DYNAMICS, INC. |
8600 WEST 14TH AVE., #2 |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
AL VASKE |
Correspondent |
LENS DYNAMICS, INC. |
8600 WEST 14TH AVE., #2 |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
AL VASKE |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 01/02/2002 |
Decision Date | 03/29/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|