The following data is part of a premarket notification filed by Retinalabs.com with the FDA for Turbo-flow Infusion Cannula 19 Gage,20 Gage,23 Gage, 25 Gage, Model 101019,101020,101023,101025.
| Device ID | K003036 |
| 510k Number | K003036 |
| Device Name: | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | RETINALABS.COM 1776 PEACHTREE ST. 200 NORTH Atlanta, GA 30309 |
| Contact | Frank Tighe |
| Correspondent | Frank Tighe RETINALABS.COM 1776 PEACHTREE ST. 200 NORTH Atlanta, GA 30309 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-29 |
| Decision Date | 2000-12-22 |