The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Ngx Microsurgical System.
| Device ID | K063331 |
| 510k Number | K063331 |
| Device Name: | BAUSCH & LOMB NGX MICROSURGICAL SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Lisa C Graney |
| Correspondent | Lisa C Graney BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-03 |
| Decision Date | 2006-12-19 |
| Summary: | summary |