The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bpz02 Multipurpose Solution.
Device ID | K083757 |
510k Number | K083757 |
Device Name: | BPZ02 MULTIPURPOSE SOLUTION |
Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
Contact | Glenn A Davies, O.d. |
Correspondent | Glenn A Davies, O.d. BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
Product Code | LYL |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-17 |
Decision Date | 2009-11-18 |
Summary: | summary |