STERRAD 100 STERILIZATION SYSTEM
Device Facts
| Record ID | K915682 |
|---|---|
| Device Name | STERRAD 100 STERILIZATION SYSTEM |
| Applicant | Johnson & Johnson Medical, Inc. |
| Product Code | FLF · General Hospital |
| Decision Date | Oct 1, 1993 |
| 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.
