The following data is part of a premarket notification filed by Irrimax Corporation with the FDA for Irrisept Antimicrobial Wound Lavage.
| Device ID | K210536 |
| 510k Number | K210536 |
| Device Name: | Irrisept Antimicrobial Wound Lavage |
| Classification | Lavage, Jet |
| Applicant | Irrimax Corporation 1665 Lakes Parkway, Suite 102 Lawrenceville, GA 30043 |
| Contact | Christy Coleman |
| Correspondent | Christy Coleman Irrimax Corporation 1665 Lakes Parkway, Suite 102 Lawrenceville, GA 30043 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-02-24 |
| Decision Date | 2021-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842351120002 | K210536 | 000 |
| 00842351110096 | K210536 | 000 |
| 00842351120033 | K210536 | 000 |