The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Pre-moistened Cleansing Pad.
Device ID | K890514 |
510k Number | K890514 |
Device Name: | PRE-MOISTENED CLEANSING PAD |
Classification | Pad, Alcohol, Device Disinfectant |
Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
Contact | Davies, O.d. |
Correspondent | Davies, O.d. BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
Product Code | LKB |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-01 |
Decision Date | 1989-04-10 |