The following data is part of a premarket notification filed by Wright Medical Corp. with the FDA for Baerveldt Glaucoma Implant.
| Device ID | K905129 |
| 510k Number | K905129 |
| Device Name: | BAERVELDT GLAUCOMA IMPLANT |
| Classification | Implant, Eye Valve |
| Applicant | WRIGHT MEDICAL CORP. P.O. BOX 800 Peapack, NJ 07977 |
| Contact | Ronald J Garutti |
| Correspondent | Ronald J Garutti WRIGHT MEDICAL CORP. P.O. BOX 800 Peapack, NJ 07977 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-14 |
| Decision Date | 1991-02-11 |