KLENZYME
Device Facts
| Record ID | K944950 |
|---|---|
| Device Name | KLENZYME |
| Applicant | Calgon Corp. |
| Product Code | FLG · General Hospital |
| Decision Date | Dec 20, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6150 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.