The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Dilator With Radiopaque Marker.
Device ID | K980282 |
510k Number | K980282 |
Device Name: | URESIL DILATOR WITH RADIOPAQUE MARKER |
Classification | Dilator, Vessel, For Percutaneous Catheterization |
Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
Contact | Lev Melinyshyn |
Correspondent | Lev Melinyshyn URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
Product Code | DRE |
CFR Regulation Number | 870.1310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-26 |
Decision Date | 1998-04-24 |