The following data is part of a premarket notification filed by Visitec Co. with the FDA for Vitreoretinal Infusion Cannula.
| Device ID | K904074 |
| 510k Number | K904074 |
| Device Name: | VITREORETINAL INFUSION CANNULA |
| Classification | Cannula, Ophthalmic |
| Applicant | VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Contact | Liaquat Allarakhia |
| Correspondent | Liaquat Allarakhia VISITEC CO. 7575 COMMERCE COURT Sarasota, FL 34243 -3218 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-04 |
| Decision Date | 1991-02-26 |