STERI-VAC GAS STERILIZER MODEL 8XL
Device Facts
| Record ID | K941748 |
|---|---|
| Device Name | STERI-VAC GAS STERILIZER MODEL 8XL |
| Applicant | 3M Health Care, Ltd. |
| Product Code | FLF · General Hospital |
| Decision Date | Dec 2, 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.
