The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Boston Xo (hexafocon A), Boston Eo (enflufocon B) And Boston Es (enflufocon A) Rigid Gas Permeable Contact Lenses.
| Device ID | K071043 |
| 510k Number | K071043 |
| Device Name: | BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Debra Ketchum |
| Correspondent | Debra Ketchum BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-12 |
| Decision Date | 2007-08-02 |
| Summary: | summary |