The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Multi-purpose Solution Nrc03.
Device ID | K031646 |
510k Number | K031646 |
Device Name: | BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 |
Classification | Accessories, Soft Lens Products |
Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
Contact | Paul G Stapleton |
Correspondent | Paul G Stapleton BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-28 |
Decision Date | 2003-11-14 |
Summary: | summary |