The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Boston Es (enflufocon A), Boston Eo (enflufocon B) And Boston Xo (hexafocon A) Rigid Gas Permeable Contact Lenses.
| Device ID | K053124 |
| 510k Number | K053124 |
| Device Name: | BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
| Contact | Lisa Graney |
| Correspondent | Lisa Graney BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-07 |
| Decision Date | 2006-01-30 |
| Summary: | summary |