The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Scleral Plug.
| Device ID | K945114 |
| 510k Number | K945114 |
| Device Name: | VISITEC SCLERAL PLUG |
| Classification | Plug, Scleral |
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Contact | David A Clapp |
| Correspondent | David A Clapp VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Product Code | LXP |
| CFR Regulation Number | 886.4155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-18 |
| Decision Date | 1995-02-23 |