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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 K843306
Device Name UVA SUNTANNING UNITS VARIOUS MODELS
Applicant
TOPSOLO SUN SYSTEMS
UNIT 3 - MARATHON PLACE
LANCS, ENGLAND, 
Applicant Contact FITTON
Correspondent
TOPSOLO SUN SYSTEMS
UNIT 3 - MARATHON PLACE
LANCS, ENGLAND, 
Correspondent Contact FITTON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/23/1984
Decision Date 10/31/1984
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
Predetermined Change
Control Plan Authorized		 No
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