The following data is part of a premarket notification filed by Suburban Ostomy Supply Co., Inc. with the FDA for Colo-tape.
| Device ID | K791146 |
| 510k Number | K791146 |
| Device Name: | COLO-TAPE |
| Classification | Cement, Stomal Appliance, Ostomy |
| Applicant | SUBURBAN OSTOMY SUPPLY CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EZR |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-18 |
| Decision Date | 1979-07-30 |