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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 K111172
Device Name 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
Applicant
DAAVLIN DISTRIBUTING CO.
205 WEST BEMENT ST.
BRYAN,  OH  43506
Applicant Contact MICHELE THIEL
Correspondent
DAAVLIN DISTRIBUTING CO.
205 WEST BEMENT ST.
BRYAN,  OH  43506
Correspondent Contact MICHELE THIEL
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/26/2011
Decision Date 08/29/2011
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
Recalls CDRH Recalls
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