K020747 is an FDA 510(k) clearance for the AMSCO CENTURY MEDIUM STERILIZER 26 X 26. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by STERIS Corporation (Erie, US). The FDA issued a Cleared decision on May 17, 2002, 71 days after receiving the submission on March 7, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K020747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2002 |
| Decision Date | May 17, 2002 |
| Days to Decision | 71 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE — Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |