K983068 is an FDA 510(k) clearance for the RELIANCE FAMILY OF WASHER-DISINFECTORS. This device is classified as a Device, Pasteurization, Hot Water (Class II - Special Controls, product code LDS).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 31, 2000, 637 days after receiving the submission on September 2, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6991.
| 510(k) Number | K983068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1998 |
| Decision Date | May 31, 2000 |
| Days to Decision | 637 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LDS — Device, Pasteurization, Hot Water |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6991 |