The following data is part of a premarket notification filed by Jung Products, Inc. with the FDA for Venes Ii.
Device ID | K811085 |
510k Number | K811085 |
Device Name: | VENES II |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | JUNG PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-21 |
Decision Date | 1981-05-01 |