The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Phaco Chop Needles.
| Device ID | K041998 |
| 510k Number | K041998 |
| Device Name: | PHACO CHOP NEEDLES |
| Classification | Unit, Phacofragmentation |
| Applicant | BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-26 |
| Decision Date | 2004-08-16 |
| Summary: | summary |