The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Fluid Administration Set Fa-3160.
| Device ID | K791020 |
| 510k Number | K791020 |
| Device Name: | FLUID ADMINISTRATION SET FA-3160 |
| Classification | Tray, Irrigation, Sterile |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EYN |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-01 |
| Decision Date | 1979-06-27 |