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 |