The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Canalicular Stent.
| Device ID | K915809 |
| 510k Number | K915809 |
| Device Name: | VISITEC CANALICULAR STENT |
| Classification | Plug, Punctum |
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Contact | David Clapp |
| Correspondent | David Clapp VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| 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 | 1991-12-24 |
| Decision Date | 1992-02-24 |