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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 K903660
Device Name DERMALIGHT PSORACOMB
Applicant
Solitec GmbH
Fraunhoferstrasse 5
Planegg,  DE D-82152
Applicant Contact SCHIMD
Correspondent
Solitec GmbH
Fraunhoferstrasse 5
Planegg,  DE D-82152
Correspondent Contact SCHIMD
Regulation Number890.5500
Classification Product Code
IOB  
Date Received08/10/1990
Decision Date 07/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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