K022816 is an FDA 510(k) clearance for the W & H LISA STEAM STERILIZER. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on February 7, 2003, 165 days after receiving the submission on August 26, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K022816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2002 |
| Decision Date | February 07, 2003 |
| Days to Decision | 165 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FLE — Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |