The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Lens Carrying Case.
Device ID | K854968 |
510k Number | K854968 |
Device Name: | BAUSCH & LOMB LENS CARRYING CASE |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
Contact | Glenn A Davies |
Correspondent | Glenn A Davies BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
Product Code | HPX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-11 |
Decision Date | 1986-04-04 |