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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 K861533
Device Name SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS
Applicant
SUNFIT, INC.
271 NORTH AVE, ROOM 407
NEW ROCHELLE,  NY  10801
Applicant Contact GEORGE W KRAUS
Correspondent
SUNFIT, INC.
271 NORTH AVE, ROOM 407
NEW ROCHELLE,  NY  10801
Correspondent Contact GEORGE W KRAUS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/24/1986
Decision Date 05/08/1986
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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