Stomahesive Paste Protective Skin Barr
FDA 510(k) K803100 · E. R. Squibb & Sons, Inc.
510(k) numberK803100
Submission
- Device name
- Stomahesive Paste Protective Skin Barr
- Applicant
- E. R. Squibb & Sons, Inc.
New York, NY, US - Received
- December 9, 1980
- Decision date
- January 8, 1981
- 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 |
| 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 |
|---|---|---|
| K821494 | Ria Stat 16JJJ · Traditional | 06/03/1982SE |
| K820616 | Angiotensis I-Squibb RadioimmunoassayCIB · Traditional | 03/26/1982SE |
| K820341 | Cortisol-Squibb Radioimmunoassay KitCGR · Traditional | 03/04/1982SE |
| K820340 | T3 Uptake-Squibb Diagnostic KitKHQ · Traditional | 03/04/1982SE |
| K811240 | Sur-Fit Loop Ostomy O.R. SetEXB · Traditional | 06/16/1981SE |
| K811239 | Sur-Fit Disposable Convex InsertEXB · Traditional | 06/09/1981SE |
| K811160 | Sur-Fit Irrigation SleeveEXD · Traditional | 06/02/1981SE |
| K811163 | Sur-Fit Disposable Fange CapEXB · Traditional | 05/21/1981SE |
| K810966 | Diagoxin Squibb Radioimmunoassay KitDNL · Traditional | 04/21/1981SE |
| K810211 | T3 Ria KitCDP · Traditional | 02/10/1981SE |
Questions and answers
When was Stomahesive Paste Protective Skin Barr cleared by the FDA?
Stomahesive Paste Protective Skin Barr (K803100) received a 510(k) decision of Substantially Equivalent on January 8, 1981, 30 days after the submission was received.
What is the product code of K803100?
The FDA product code is EZR – Cement, Stomal Appliance, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.