THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
Device Facts
| Record ID | K931872 |
|---|---|
| Device Name | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER |
| Applicant | American Sterilizer Co. |
| Product Code | FLF · General Hospital |
| Decision Date | Feb 7, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6860 |
| Device Class | Class 2 |
Regulatory Classification
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.
