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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 K080779
Device Name IRRISEPT WOUND CLEANSING SYSTEM
Applicant
Irrimax Corporation
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Applicant Contact JULIE STEPHENS
Correspondent
Irrimax Corporation
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact JULIE STEPHENS
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received03/19/2008
Decision Date 02/04/2009
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
Recalls CDRH Recalls
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