The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Nephro-ureteral Stent.
| Device ID | K980889 |
| 510k Number | K980889 |
| Device Name: | URESIL NEPHRO-URETERAL STENT |
| Classification | Catheter, Nephrostomy |
| 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 | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-09 |
| Decision Date | 1998-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H862NSL21028H2 | K980889 | 000 |
| 10817640020537 | K980889 | 000 |
| 10817640020520 | K980889 | 000 |
| 10817640020513 | K980889 | 000 |
| 10817640020193 | K980889 | 000 |
| 10817640020186 | K980889 | 000 |
| 10817640020179 | K980889 | 000 |
| 10817640020162 | K980889 | 000 |
| 10817640020452 | K980889 | 000 |
| 10817640020445 | K980889 | 000 |
| 10817640020438 | K980889 | 000 |
| 10817640020421 | K980889 | 000 |
| 10817640020414 | K980889 | 000 |
| 10817640020407 | K980889 | 000 |
| 10817640020391 | K980889 | 000 |
| 10817640020544 | K980889 | 000 |
| H862NSL2T0822H1 | K980889 | 000 |
| H862NSL21026H2 | K980889 | 000 |
| H862NSL21024H2 | K980889 | 000 |
| H862NSL21022H2 | K980889 | 000 |
| H862NSL20828H2 | K980889 | 000 |
| H862NSL20826H2 | K980889 | 000 |
| H862NSL20824H2 | K980889 | 000 |
| H862NSL20822H2 | K980889 | 000 |
| H862NSL2T1028H1 | K980889 | 000 |
| H862NSL2T1026H1 | K980889 | 000 |
| H862NSL2T1024H1 | K980889 | 000 |
| H862NSL2T1022H1 | K980889 | 000 |
| H862NSL2T0828H1 | K980889 | 000 |
| H862NSL2T0826H1 | K980889 | 000 |
| H862NSL2T0824H1 | K980889 | 000 |
| 10817640020384 | K980889 | 000 |