The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch + Lomb Injector System.
Device ID | K151102 |
510k Number | K151102 |
Device Name: | Bausch + Lomb Injector System |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
Contact | Joyce Zhong |
Correspondent | Joyce Zhong Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
Product Code | MSS |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-24 |
Decision Date | 2015-05-22 |
Summary: | summary |