EZR · Cement, Stomal Appliance, Ostomy
Gastroenterology, Urology · 21 CFR 876.5900 · Class 1
Overview
| Product Code | EZR |
|---|---|
| Device Name | Cement, Stomal Appliance, Ostomy |
| Regulation | 21 CFR 876.5900 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K844341 | UNITED SKIN BARRIER PASTE | Howmedica Corp. | Jan 18, 1985 | SESE |
| K803100 | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | E. R. Squibb & Sons, Inc. | Jan 8, 1981 | SESE |
| K791146 | COLO-TAPE | Suburban Ostomy Supply Co., Inc. | Jul 30, 1979 | SESE |
| K761340 | OSTOMY KARAYA GUM POWDER | Howmedica Corp. | Mar 7, 1977 | SESE |
| K770230 | KARAYA GUM POWDER | Atlantic Surgical | Feb 28, 1977 | SESE |
| K761319 | KARAYA GUM PRODUCTS - PROCESS CHANGE | Howmedica Corp. | Feb 15, 1977 | SESE |
Top Applicants
- Howmedica Corp. — 3 clearances
- Atlantic Surgical — 1 clearance
- E. R. Squibb & Sons, Inc. — 1 clearance
- Suburban Ostomy Supply Co., Inc. — 1 clearance
