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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light, ultraviolet, dermatological
510(k) Number K150912
Device Name Houva-NET Control System
National Biological Corporation
23700 Mercantile Road
Beachwood,  OH  44122
Applicant Contact Lynn Keller
REU Associates Inc.
409 Woodridge Dr.
Seneca,  SC  29672
Correspondent Contact Jennifer Cartledge
Regulation Number878.4630
Classification Product Code
Date Received04/03/2015
Decision Date 07/10/2015
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