URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET— 510(k) K903449

Name: FDA 510(k) clearance K903449
Creator: U.S. Food and Drug Administration
Published: 1990-09-12

Substantially Equivalent

Uresil Corp.

FDA 510(k) clearance K903449 for URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET, Substantially Equivalent on 1990-09-12. Applicant: Uresil Corp.. Device class: 2.

Clearance details

Applicant: Uresil Corp.
Product code: Code EXF
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 1990-07-30
Decision date: 1990-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXF

view all

K003078 — MERIT DRAINAGE DEPOT2000-12-11
K990428 — DRAINAGE BAG1999-08-12
K980005 — MANAN D BAG1998-01-30
K961986 — MANAN D BAG1997-03-13
K963849 — MANAN D BAG1996-12-13

More clearances from Uresil Corp.

view all

K003753 — GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE2001-01-04
K980278 — URESIL VASCU-FLO INFUSION CATHETER1998-11-20
K981344 — URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING1998-09-10
K980282 — URESIL DILATOR WITH RADIOPAQUE MARKER1998-04-24
K980889 — URESIL NEPHRO-URETERAL STENT1998-04-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.