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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 K063621
Device Name 3 SERIES PHOTOTHERAPY CABINET
Applicant
DAAVLIN CO.
205 WEST BEMENT ST.
P.O. BOX 626
BRYAN,  OH  43506
Applicant Contact TARA MANSUR
Correspondent
DAAVLIN CO.
205 WEST BEMENT ST.
P.O. BOX 626
BRYAN,  OH  43506
Correspondent Contact TARA MANSUR
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/05/2006
Decision Date 01/17/2007
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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