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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 K812521
Device Name SUNTANNING DEVICE (SEPAR. FROM K812225)
Applicant
KLAFS SUNLIGHT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KLAFS SUNLIGHT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/02/1981
Decision Date 10/02/1981
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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