United Skin Barrier Paste
FDA 510(k) K844341 · Howmedica Corp.
510(k) numberK844341
Submission
- Device name
- United Skin Barrier Paste
- Applicant
- Howmedica Corp.
Ny, NY, US - Received
- November 8, 1984
- Decision date
- January 18, 1985
- 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 |
|---|---|---|---|
| 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 |
More from Howmedica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| 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 United Skin Barrier Paste cleared by the FDA?
United Skin Barrier Paste (K844341) received a 510(k) decision of Substantially Equivalent on January 18, 1985, 71 days after the submission was received.
What is the product code of K844341?
The FDA product code is EZR – Cement, Stomal Appliance, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.