The following data is part of a premarket notification filed by Jung Products, Inc. with the FDA for Venes Custon Rx.
| Device ID | K820484 |
| 510k Number | K820484 |
| Device Name: | VENES CUSTON RX |
| Classification | Stocking, Medical Support (for General Medical Purposes) |
| Applicant | JUNG PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-22 |
| Decision Date | 1982-03-18 |