The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Cybercases By Bausch & Lomb.
Device ID | K013232 |
510k Number | K013232 |
Device Name: | CYBERCASES BY BAUSCH & LOMB |
Classification | Case, Contact Lens |
Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O. BOX 30450 Rochester, NY 14609 |
Contact | Kim S Devitto |
Correspondent | Kim S Devitto BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O. BOX 30450 Rochester, NY 14609 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-27 |
Decision Date | 2001-11-20 |
Summary: | summary |