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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 K152533
Device Name Xonrid Gel
Applicant
Helsinn Healthcare SA
Via Pain Scairolo 9
Lugano,  CH 6912
Applicant Contact Valentina Tombolini Bossi
Correspondent
Buchanan Ingersoll & Rooney PC
1700 K St., NW, Suite 300
Washington,  DC  20006
Correspondent Contact Barbara A Binzak Blumenfeld
Classification Product Code
FRO  
Date Received09/03/2015
Decision Date 10/28/2016
Decision Substantially Equivalent (SESE)
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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