The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Retinal Detachment Implants; Including Bans, Strips, Tires, Sleeves, Cords And Sponges.
| Device ID | K963219 |
| 510k Number | K963219 |
| Device Name: | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES |
| Classification | Implant, Orbital, Extra-ocular |
| Applicant | FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. Marshfield Hills, MA 02051 |
| Contact | Anne Bohsack |
| Correspondent | Anne Bohsack FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. Marshfield Hills, MA 02051 |
| Product Code | HQX |
| CFR Regulation Number | 886.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-16 |
| Decision Date | 1996-10-28 |