The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Nnr06 Multi-purpose Solution.
Device ID | K161819 |
510k Number | K161819 |
Device Name: | NNR06 Multi-Purpose Solution |
Classification | Accessories, Soft Lens Products |
Applicant | Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609 |
Contact | Glenn Davies |
Correspondent | Glenn Davies 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 | 2016-07-01 |
Decision Date | 2016-11-25 |
Summary: | summary |