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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 K022104
Device Name DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ
Applicant
Daavlin Distributing Co.
205 W. Bement St.
Bryan,  OH  43506
Applicant Contact CHAD REYNOLDS
Correspondent
Daavlin Distributing Co.
205 W. Bement St.
Bryan,  OH  43506
Correspondent Contact CHAD REYNOLDS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/28/2002
Decision Date 09/10/2002
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
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