K082817 is an FDA 510(k) clearance for the PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Primus Sterilizer Company, LLC (Great Bend, US). The FDA issued a Cleared decision on May 21, 2009, 238 days after receiving the submission on September 25, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K082817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2008 |
| Decision Date | May 21, 2009 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| 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 |