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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 K050695
Device Name FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT
Applicant
DAAVLIN DISTRIBUTING CO.
205 WEST BEMENT ST.
BRYAN,  OH  43506
Applicant Contact DAVID W SWANSON
Correspondent
DAAVLIN DISTRIBUTING CO.
205 WEST BEMENT ST.
BRYAN,  OH  43506
Correspondent Contact DAVID W SWANSON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/18/2005
Decision Date 04/19/2005
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
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