Cement, Stomal Appliance, Ostomy
FDA product code EZR · Class I (low risk) · 21 CFR 876.5900 · Gastroenterology, Urology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K844341 | United Skin Barrier PasteEZR · Traditional | Howmedica Corp. | 01/18/1985SE |
| K803100 | Stomahesive Paste Protective Skin BarrEZR · Traditional | E. R. Squibb & Sons, Inc. | 01/08/1981SE |
| K791146 | Colo-TapeEZR · Traditional | Suburban Ostomy Supply Co., Inc. | 07/30/1979SE |
| K761340 | Ostomy Karaya Gum PowderEZR · Traditional | Howmedica Corp. | 03/07/1977SE |
| K770230 | Karaya Gum PowderEZR · Traditional | Atlantic Surgical | 02/28/1977SE |
| K761319 | Karaya Gum Products - Process ChangeEZR · Traditional | Howmedica Corp. | 02/15/1977SE |