The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Abt12 Multi-purpose Solution.
Device ID | K202932 |
510k Number | K202932 |
Device Name: | ABT12 Multi-purpose Solution |
Classification | Accessories, Soft Lens Products |
Applicant | Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
Contact | Melissa Thomas |
Correspondent | Melissa Thomas Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-29 |
Decision Date | 2021-05-28 |