K041833 is an FDA 510(k) clearance for the CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Consolidated Machine Corp. (Boston, US). The FDA issued a Cleared decision on December 10, 2004, 156 days after receiving the submission on July 7, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K041833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2004 |
| Decision Date | December 10, 2004 |
| Days to Decision | 156 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 |