The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Silicone Retinal Implants/explants.
| Device ID | K945172 |
| 510k Number | K945172 |
| Device Name: | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS |
| Classification | Implant, Orbital, Extra-ocular |
| 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 | HQX |
| CFR Regulation Number | 886.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-21 |
| Decision Date | 1995-01-17 |