Product code EZR
- Device name
- Cement, Stomal Appliance, Ostomy
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5900
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844341 | UNITED SKIN BARRIER PASTE | Howmedica Corp. | 1985-01-18 |
| K803100 | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | E. R. Squibb & Sons, Inc. | 1981-01-08 |
| K791146 | COLO-TAPE | Suburban Ostomy Supply Co., Inc. | 1979-07-30 |
| K761340 | OSTOMY KARAYA GUM POWDER | Howmedica Corp. | 1977-03-07 |
| K770230 | KARAYA GUM POWDER | Atlantic Surgical | 1977-02-28 |
| K761319 | KARAYA GUM PRODUCTS - PROCESS CHANGE | Howmedica Corp. | 1977-02-15 |
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|---|---|---|---|
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| 06950715505663 | cofoe | Cofoe Medical Technology Co.,Ltd | 2024-12-09 |
| 06950715505656 | cofoe | Cofoe Medical Technology Co.,Ltd | 2024-12-09 |
| 06950715505649 | cofoe | Cofoe Medical Technology Co.,Ltd | 2024-12-09 |
| 06948909454736 | Bynex | Shaoxing Haoshide Medical Products Co., Ltd. | 2024-08-22 |
| 06948909454729 | Bynex | Shaoxing Haoshide Medical Products Co., Ltd. | 2024-08-22 |
| 06948909454712 | Bynex | Shaoxing Haoshide Medical Products Co., Ltd. | 2024-08-21 |
| 06948909454705 | Bynex | Shaoxing Haoshide Medical Products Co., Ltd. | 2024-08-21 |
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