EZR — Cement, Stomal Appliance, Ostomy Class I
FDA product code EZR covers "Cement, Stomal Appliance, Ostomy", a Class I medical device regulated under 21 CFR 876.5900. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EZR
- Device Class
- Class I
- Regulation Number
- 876.5900
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K844341 | howmedica | UNITED SKIN BARRIER PASTE | January 18, 1985 |
| K803100 | e. r. squibb and sons | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | January 8, 1981 |
| K791146 | suburban ostomy supply co | COLO-TAPE | July 30, 1979 |
| K761340 | howmedica | OSTOMY KARAYA GUM POWDER | March 7, 1977 |
| K770230 | atlantic surgical | KARAYA GUM POWDER | February 28, 1977 |
| K761319 | howmedica | KARAYA GUM PRODUCTS - PROCESS CHANGE | February 15, 1977 |