← Product Code [FLF](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF) · K910649

# MDT/CASTLE 10/90 LOAD STATION (K910649)

_Mdt Biologic Co. · FLF · Sep 6, 1991 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K910649

## Device Facts

- **Applicant:** Mdt Biologic Co.
- **Product Code:** [FLF](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF.md)
- **Decision Date:** Sep 6, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6860
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K910649](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FLF/K910649)

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