← Product Code [EXB](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB) · K871628

# PALEX (R) OSTOMY (K871628)

_Industrias Palex C/O Dma Med-Chem Corp. · EXB · Jul 8, 1987 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K871628

## Device Facts

- **Applicant:** Industrias Palex C/O Dma Med-Chem Corp.
- **Product Code:** [EXB](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB.md)
- **Decision Date:** Jul 8, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5900
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K871628](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EXB/K871628)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
