DECOMAT 4656
Device Facts
| Record ID | K950566 |
|---|---|
| Device Name | DECOMAT 4656 |
| Applicant | Getinge Disinfection, Inc. |
| Product Code | LDS · General Hospital |
| Decision Date | Oct 19, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6991 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
