FDA.report

510(k) K202222

Device
Irrisept Wound Debridement and Cleansing System
Applicant
Irrimax Corporation
510(k) number
K202222
Product code
FQH
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-14
Date received
2020-08-06
Regulation
880.5475
Classification name
Lavage, Jet
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Christy Coleman
Address
1665 Lakes Pkwy. - Suite 102 Lawrenceville GA US 30043 30043

FDA Registration Numbers

Source Documents

510(k) summary PDF

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