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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 K760482
Device Name SUNLAMP (F40-UVB & F20-UVB)
Original Applicant
DERMATRON CORP.
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/19/1976
Decision Date 09/15/1976
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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