URIHESIVE STRIP— 510(k) K915616

Name: FDA 510(k) clearance K915616
Creator: U.S. Food and Drug Administration
Published: 1992-01-23

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K915616 for URIHESIVE STRIP, Substantially Equivalent on 1992-01-23. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: 1.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code EXI
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1991-12-16
Decision date: 1992-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXI

view all

K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCH1997-08-28
K970443 — HOLLISTER RETRACTED PENIS POUCH1997-02-25
K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE1997-01-10
K931277 — HOLLISTER PREMIUM URINE COLLECTOR1993-06-23
K924755 — CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION1993-06-22

More clearances from Convatec, A Division of E.R. Squibb & Sons

view all

K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING2002-06-21
K990964 — SIGNADRESS DUODERM DRESSING1999-05-18
K984388 — HA ABSORBENT WOUND DRESSING1999-03-03
K980720 — NONWOVEN PAD1998-04-15
K980382 — NON-WOVEN COMPRESS1998-03-09

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