K090036 is an FDA 510(k) clearance for the SYSTEM 1.5 STERILE PROCESSING SYSTEM. This device is classified as a Sterilant, Medical Devices (Class II - Special Controls, product code MED).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 5, 2010, 454 days after receiving the submission on January 6, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K090036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2009 |
| Decision Date | April 05, 2010 |
| Days to Decision | 454 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6885 |