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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 K801017
Device Name TANIT COMMERCIAL SUNTAN BOOTH
Applicant
TANIT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TANIT, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/30/1980
Decision Date 06/17/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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