Clearance Summary
COLOSTOMY BAG received FDA 510(k) clearance under submission number K830841, sponsored by C & D Colostomy Pad Corp.. 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 1983-07-19.
- Submission: K830841
- Applicant / Sponsor: C & D Colostomy Pad Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 1983-07-19
Classification & Regulation
This clearance is catalogued under FDA product code EXB and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.