Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K071266 |
Device Name |
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS |
Applicant |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609 -3547
|
|
Applicant Contact |
MICHAEL A SANTALUCIA |
Correspondent |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609 -3547
|
|
Correspondent Contact |
MICHAEL A SANTALUCIA |
Regulation Number | 886.5916
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/07/2007 |
Decision Date | 08/15/2007 |
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
|
|
|