| Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
| 510(k) Number |
K000529 |
| Device Name |
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) |
| Applicant |
| The Lifestyle Co., Inc. |
| 712 Ginesi Dr. |
|
Morganville,
NJ
07751
|
|
| Applicant Contact |
MARTIN RIEHM |
| Correspondent |
| The Lifestyle Co., Inc. |
| 712 Ginesi Dr. |
|
Morganville,
NJ
07751
|
|
| Correspondent Contact |
MARTIN RIEHM |
| Regulation Number | 886.5925 |
| Classification Product Code |
|
| Date Received | 02/17/2000 |
| Decision Date | 03/21/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|