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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 K100378
Device Name 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
Applicant
Daavlin Distributing Co.
205 W. Bement St.
Bryan,  OH  43506
Applicant Contact MICHELE THIEL
Correspondent
Daavlin Distributing Co.
205 W. Bement St.
Bryan,  OH  43506
Correspondent Contact MICHELE THIEL
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/16/2010
Decision Date 04/28/2010
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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