EZR · Class I · 21 CFR 876.5900

FDA Product Code EZR: Cement, Stomal Appliance, Ostomy

Leading manufacturers include Howmedica Corp., Atlantic Surgical and Suburban Ostomy Supply Co., Inc..

6
Total
6
Cleared
47d
Avg days
1977
Since

FDA 510(k) Cleared Cement, Stomal Appliance, Ostomy Devices (Product Code EZR)

6 devices
1–6 of 6
Cleared Jan 18, 1985
UNITED SKIN BARRIER PASTE
K844341
Howmedica Corp.
Gastroenterology & Urology · 71d
Cleared Jan 08, 1981
STOMAHESIVE PASTE PROTECTIVE SKIN BARR
K803100
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 30, 1979
COLO-TAPE
K791146
Suburban Ostomy Supply Co., Inc.
Gastroenterology & Urology · 42d
Cleared Mar 07, 1977
OSTOMY KARAYA GUM POWDER
K761340
Howmedica Corp.
Gastroenterology & Urology · 69d
Cleared Feb 28, 1977
KARAYA GUM POWDER
K770230
Atlantic Surgical
Gastroenterology & Urology · 21d
Cleared Feb 15, 1977
KARAYA GUM PRODUCTS - PROCESS CHANGE
K761319
Howmedica Corp.
Gastroenterology & Urology · 50d

About Product Code EZR - Regulatory Context