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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 K202222
Device Name Irrisept Wound Debridement and Cleansing System
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 Received08/06/2020
Decision Date 12/14/2020
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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