Irrisept Antimicrobial Wound Lavage

Lavage, Jet

Irrimax Corporation

The following data is part of a premarket notification filed by Irrimax Corporation with the FDA for Irrisept Antimicrobial Wound Lavage.

Pre-market Notification Details

Device IDK210536
510k NumberK210536
Device Name:Irrisept Antimicrobial Wound Lavage
ClassificationLavage, Jet
Applicant Irrimax Corporation 1665 Lakes Parkway, Suite 102 Lawrenceville,  GA  30043
ContactChristy Coleman
CorrespondentChristy Coleman
Irrimax Corporation 1665 Lakes Parkway, Suite 102 Lawrenceville,  GA  30043
Product CodeFQH  
CFR Regulation Number880.5475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-02-24
Decision Date2021-05-28

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