The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Osl-2000 Slit Lamp.
Device ID | K862516 |
510k Number | K862516 |
Device Name: | BAUSCH & LOMB OSL-2000 SLIT LAMP |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
Contact | Nicholas A Walp |
Correspondent | Nicholas A Walp BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-01 |
Decision Date | 1986-07-11 |