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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K160379
Device Name Exufiber Ag+
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
Classification Product Code
FRO  
Date Received02/10/2016
Decision Date 08/25/2016
Decision Substantially Equivalent (SESE)
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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