Clearance Summary
MARLEN ULTRA ILEOSTOMY POUCH-5000 received FDA 510(k) clearance under submission number K880327, sponsored by Marlen Mfg. & Development Co.. 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 1988-02-19.
- Submission: K880327
- Applicant / Sponsor: Marlen Mfg. & Development Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 1988-02-19
Classification & Regulation
This clearance is catalogued under FDA product code EZQ and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.