Karaya Gum Products - Process Change
FDA 510(k) K761319 · Howmedica Corp.
510(k) numberK761319
Submission
- Device name
- Karaya Gum Products - Process Change
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- December 27, 1976
- Decision date
- February 15, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EZR – Cement, Stomal Appliance, Ostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZR
| 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 |
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| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Karaya Gum Products - Process Change cleared by the FDA?
Karaya Gum Products - Process Change (K761319) received a 510(k) decision of Substantially Equivalent on February 15, 1977, 50 days after the submission was received.
What is the product code of K761319?
The FDA product code is EZR – Cement, Stomal Appliance, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.