The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Ureteral Stant Set.
Device ID | K820870 |
510k Number | K820870 |
Device Name: | URETERAL STANT SET |
Classification | Stent, Ureteral |
Applicant | VAN-TEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FAD |
CFR Regulation Number | 876.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-29 |
Decision Date | 1982-04-26 |