K091136 is an FDA 510(k) clearance for the AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on June 29, 2009, 70 days after receiving the submission on April 20, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K091136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2009 |
| Decision Date | June 29, 2009 |
| Days to Decision | 70 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 |