K093333 is an FDA 510(k) clearance for the PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Primus Sterilizer Company, LLC (Omaha, US). The FDA issued a Cleared decision on April 2, 2010, 158 days after receiving the submission on October 26, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K093333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2009 |
| Decision Date | April 02, 2010 |
| Days to Decision | 158 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 |