Clearance Summary
PALEX (R) OSTOMY received FDA 510(k) clearance under submission number K871628, sponsored by Industrias Palex C/O Dma Med-Chem 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 1987-07-08.
- Submission: K871628
- Applicant / Sponsor: Industrias Palex C/O Dma Med-Chem Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 1987-07-08
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.