← Product Code [FLE](/productcode/FLE) · K912471

# EAGLE 3000 SDS (K912471)

_Amsco Co. · FLE · Jun 26, 1992 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K912471

## Device Facts

- **Applicant:** Amsco Co.
- **Product Code:** [FLE](/productcode/FLE.md)
- **Decision Date:** Jun 26, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6880
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

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**Source:** [https://fda.innolitics.com/device/K912471](https://fda.innolitics.com/device/K912471)

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