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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 K150914
Device Name Dash-Topic Plus Cream
Applicant
Founders Science Group, LLC
400 Highland Corporate Dr.
Cumberland,  RI  02864
Applicant Contact Ronald M Gurge
Correspondent
Founders Science Group, LLC
400 Highland Corporate Dr.
Cumberland,  RI  02864
Correspondent Contact Ronald M Gurge
Classification Product Code
FRO  
Subsequent Product Code
MGQ  
Date Received04/06/2015
Decision Date 04/21/2016
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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