The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Vpi-fair Urethral Stent.
Device ID | K820313 |
510k Number | K820313 |
Device Name: | VPI-FAIR URETHRAL STENT |
Classification | Catheter, Urological |
Applicant | VANCE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-05 |
Decision Date | 1982-03-01 |