MDT/CASTLE 10/90 LOAD STATION
Device Facts
| Record ID | K910649 |
|---|---|
| Device Name | MDT/CASTLE 10/90 LOAD STATION |
| Applicant | Mdt Biologic Co. |
| Product Code | FLF · General Hospital |
| Decision Date | Sep 6, 1991 |
| 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.