The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Nephro-ureteral Stent.
Device ID | K942688 |
510k Number | K942688 |
Device Name: | NEPHRO-URETERAL STENT |
Classification | Catheter, Nephrostomy |
Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
Contact | Matthew Curtis |
Correspondent | Matthew Curtis URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
Product Code | LJE |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-07 |
Decision Date | 1995-06-06 |