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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K210536
Device Name Irrisept Antimicrobial Wound Lavage
Applicant
Irrimax Corporation
1665 Lakes Pkwy.
Suite 102
Lawrenceville,  GA  30043
Applicant Contact Christy Coleman
Correspondent
Irrimax Corporation
1665 Lakes Pkwy.
Suite 102
Lawrenceville,  GA  30043
Correspondent Contact Christy Coleman
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received02/24/2021
Decision Date 05/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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