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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
510(k) Number K130852
Device Name AVANCE® FOAM ABDOMINAL DRESSING KIT
Applicant
Molnlycke Health Care
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact ANGELA L BUNN
Correspondent
Molnlycke Health Care
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact ANGELA L BUNN
Regulation Number878.3300
Classification Product Code
OXJ  
Subsequent Product Code
OMP  
Date Received03/28/2013
Decision Date 04/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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