Clearance Summary
COLO-TAPE received FDA 510(k) clearance under submission number K791146, sponsored by Suburban Ostomy Supply Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1979-07-30.
- Submission: K791146
- Applicant / Sponsor: Suburban Ostomy Supply Co., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 1979-07-30
Classification & Regulation
This clearance is catalogued under FDA product code EZR and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.