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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 K072035
Device Name RESOLVE UVB PHOTOTHERAPY SYSTEM
Applicant
Allux Medical
1430 O'Brien Dr.
Suite F
Menlo Park,  CA  94025
Applicant Contact LLOYD H GRIESE
Correspondent
Allux Medical
1430 O'Brien Dr.
Suite F
Menlo Park,  CA  94025
Correspondent Contact LLOYD H GRIESE
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/25/2007
Decision Date 10/16/2007
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
Predetermined Change
Control Plan Authorized		 No
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