The following data is part of a premarket notification filed by Irrimax Corporation with the FDA for Irrisept Wound Cleansing System.
| Device ID | K080779 |
| 510k Number | K080779 |
| Device Name: | IRRISEPT WOUND CLEANSING SYSTEM |
| Classification | Lavage, Jet |
| Applicant | IRRIMAX CORPORATION 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Contact | Julie Stephens |
| Correspondent | Julie Stephens IRRIMAX CORPORATION 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-03-19 |
| Decision Date | 2009-02-04 |
| Summary: | summary |