K080779 is an FDA 510(k) clearance for the IRRISEPT WOUND CLEANSING SYSTEM, a Lavage, Jet (Class II — Special Controls, product code FQH), submitted by Irrimax Corporation (Alpharetta, US). The FDA issued a Cleared decision on February 4, 2009, 322 days after receiving the submission on March 19, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K080779 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 2008 |
| Decision Date | February 04, 2009 |
| Days to Decision | 322 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5475 |