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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 K042502
Device Name 3 SERIES PHOTOTHERAPY CABINET
Applicant
Daavlin Distributing Co.
205 W. Bement St.
Bryan,  OH  43506
Applicant Contact DAVID W SWANSON
Correspondent
Daavlin Distributing Co.
205 W. Bement St.
Bryan,  OH  43506
Correspondent Contact DAVID W SWANSON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/14/2004
Decision Date 10/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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