Device Classification Name |
accessories, solution, ultrasonic cleaners for lenses
|
510(k) Number |
K083757 |
Device Name |
BPZ02 MULTIPURPOSE SOLUTION |
Applicant |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609 -3547
|
|
Applicant Contact |
GLENN A DAVIES, O.D. |
Correspondent |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609 -3547
|
|
Correspondent Contact |
GLENN A DAVIES, O.D. |
Regulation Number | 886.5928
|
Classification Product Code |
|
Date Received | 12/17/2008 |
Decision Date | 11/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00636363
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|