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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 K151168
Device Name Nexodyn AOS Wound Care Solution
Applicant
Apr Applied Pharma Research SA
Via Corti 5
Balerna,  CH 6828
Applicant Contact Giorgio Reiner
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Classification Product Code
FRO  
Date Received05/01/2015
Decision Date 12/22/2015
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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