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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 K853752
Device Name SUN KING
Applicant
AMERICAN CHASE COMPANY, INC.
663 FIFTH AVE.
NEW YORK,  NY  10022
Applicant Contact NYSTROM
Correspondent
AMERICAN CHASE COMPANY, INC.
663 FIFTH AVE.
NEW YORK,  NY  10022
Correspondent Contact NYSTROM
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/09/1985
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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