K950566 is an FDA 510(k) clearance for the DECOMAT 4656. This device is classified as a Device, Pasteurization, Hot Water (Class II - Special Controls, product code LDS).
Submitted by Getinge Disinfection, Inc. (Toms River, US). The FDA issued a Cleared decision on October 19, 1995, 253 days after receiving the submission on February 8, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6991.
| 510(k) Number | K950566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1995 |
| Decision Date | October 19, 1995 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LDS — Device, Pasteurization, Hot Water |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6991 |