The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ureteral Stent.
Device ID | K823487 |
510k Number | K823487 |
Device Name: | BARD URETERAL STENT |
Classification | Stent, Ureteral |
Applicant | C.R. BARD, 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 | 1982-11-23 |
Decision Date | 1983-05-27 |