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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 K853911
Device Name UV-A SUNTANNING EQUIPMENT
Applicant
EUROTAN INTL.
3701 MONTROSE BLVD.
HOUSTON,  TX  77006
Applicant Contact HANS-WILLI ROTHEUDT
Correspondent
EUROTAN INTL.
3701 MONTROSE BLVD.
HOUSTON,  TX  77006
Correspondent Contact HANS-WILLI ROTHEUDT
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/20/1985
Decision Date 10/21/1985
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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