Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K081034 |
Device Name |
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS |
Applicant |
Synergeyes, Inc. |
15825 SHADY GROVE ROAD |
SUITE 30 |
ROCKVILLE,
MD
20850
|
|
Applicant Contact |
RICHARD E LIPPMAN |
Correspondent |
Synergeyes, Inc. |
15825 SHADY GROVE ROAD |
SUITE 30 |
ROCKVILLE,
MD
20850
|
|
Correspondent Contact |
RICHARD E LIPPMAN |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 04/11/2008 |
Decision Date | 05/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|