The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Punctum Plugs & Ready-set Punctal Plugs.
| Device ID | K964774 |
| 510k Number | K964774 |
| Device Name: | PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS |
| Classification | Plug, Punctum |
| 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 | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-22 |
| Decision Date | 1996-12-20 |