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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 K860489
Device Name EUROTAN BY AYK
Applicant
Eurotan Intl.
One Greenway Plz.
Suite 525
Houston,  TX  77046
Applicant Contact HANS-WILLI ROTHEUDT
Correspondent
Eurotan Intl.
One Greenway Plz.
Suite 525
Houston,  TX  77046
Correspondent Contact HANS-WILLI ROTHEUDT
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/10/1986
Decision Date 02/24/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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