Colo-Tape
FDA 510(k) K791146 · Suburban Ostomy Supply Co., Inc.
510(k) numberK791146
Submission
- Device name
- Colo-Tape
- Applicant
- Suburban Ostomy Supply Co., Inc.
Mchenry, IL, US - Received
- June 18, 1979
- Decision date
- July 30, 1979
- 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 |
| 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 |
Questions and answers
When was Colo-Tape cleared by the FDA?
Colo-Tape (K791146) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 42 days after the submission was received.
What is the product code of K791146?
The FDA product code is EZR – Cement, Stomal Appliance, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.