Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K053124 |
Device Name |
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES |
Applicant |
BAUSCH & LOMB INCORPORATED |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609
|
|
Applicant Contact |
LISA GRANEY |
Correspondent |
BAUSCH & LOMB INCORPORATED |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609
|
|
Correspondent Contact |
LISA GRANEY |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 11/07/2005 |
Decision Date | 01/30/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|