Device Classification Name |
accessories, soft lens products
|
510(k) Number |
K202932 |
Device Name |
ABT12 multi-purpose solution |
Applicant |
Bausch & Lomb Incorporated |
1400 North Goodman Street |
Rochester,
NY
14609
|
|
Applicant Contact |
Melissa Thomas |
Correspondent |
Bausch & Lomb Incorporated |
1400 North Goodman Street |
Rochester,
NY
14609
|
|
Correspondent Contact |
Melissa Thomas |
Regulation Number | 886.5928
|
Classification Product Code |
|
Date Received | 09/29/2020 |
Decision Date | 05/28/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03897751
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|