K092482 is an FDA 510(k) clearance for the TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500, a System, Suction, Lipoplasty (Class II — Special Controls, product code MUU), submitted by Shippert Medical Technologies Corp. (Centennial, US). The FDA issued a Cleared decision on December 4, 2009, 113 days after receiving the submission on August 13, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5040.
| 510(k) Number | K092482 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 2009 |
| Decision Date | December 04, 2009 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUU — System, Suction, Lipoplasty |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5040 |
| Definition | See Federal Register Notice At 86 Fr 50887 ?consolidation Of Devices That Process Autologous Human Cells, Tissues, And Cellular And Tissue-based Products At The Point Of Care To Produce A Therapeutic Article? (frn) (fda-2021-n-0881). |