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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Non Heating
510(k) Number K760519
Device Name SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313
Applicant
Dermatron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dermatron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5500
Classification Product Code
IOB  
Date Received08/26/1976
Decision Date 09/03/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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