The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Entry Site Alignment System Model # Cx9626.
| Device ID | K012435 |
| 510k Number | K012435 |
| Device Name: | ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 |
| Classification | Cannula, Trocar, Ophthalmic |
| Applicant | BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Vanada Johnson |
| Correspondent | Vanada Johnson BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | NGY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-31 |
| Decision Date | 2001-10-02 |
| Summary: | summary |