The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions.
Device ID | K173089 |
510k Number | K173089 |
Device Name: | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions |
Classification | Products, Contact Lens Care, Rigid Gas Permeable |
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 | MRC |
CFR Regulation Number | 886.5918 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2017-11-27 |
Summary: | summary |