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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K161935
Device Name Avance Foam Dressing Kit - XL
Applicant
Molnlycke Health Care Us, LLC
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Applicant Contact MEGAN BEVILL
Correspondent
Molnlycke Health Care Us, LLC
5550 Peachtree Pkwy., Suite 500
Norcross,  GA  30092
Correspondent Contact MEGAN BEVILL
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/14/2016
Decision Date 11/04/2016
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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