The following data is part of a premarket notification filed by Pharmacia Iovision, Inc. with the FDA for Baervelt Pars Plana Glaucoma Implant.
| Device ID | K955455 |
| 510k Number | K955455 |
| Device Name: | BAERVELT PARS PLANA GLAUCOMA IMPLANT |
| Classification | Implant, Eye Valve |
| Applicant | PHARMACIA IOVISION, INC. P.O. BOX 800 Peapack, NJ 07977 |
| Contact | Ronald J Garutti |
| Correspondent | Ronald J Garutti PHARMACIA IOVISION, INC. 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 | 1995-11-29 |
| Decision Date | 1997-02-18 |
| Summary: | summary |