Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K082132 |
Device Name |
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK |
Applicant |
BAUSCH & LOMB, INC |
1400 North Goodman Street |
Rochester,
NY
14609
|
|
Applicant Contact |
NED LUCE |
Correspondent |
BAUSCH & LOMB, INC |
1400 North Goodman Street |
Rochester,
NY
14609
|
|
Correspondent Contact |
NED LUCE |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/29/2008 |
Decision Date | 08/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|