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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 K854224
Device Name GOLDEN RULE SUN TANNING BEDS
Applicant
Golden Rule Tanning Co., Inc.
P.O. Box 23224
Chattanooga,  TN  37422
Applicant Contact DOUGLAS BEDWELL
Correspondent
Golden Rule Tanning Co., Inc.
P.O. Box 23224
Chattanooga,  TN  37422
Correspondent Contact DOUGLAS BEDWELL
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/18/1985
Decision Date 11/08/1985
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
Predetermined Change
Control Plan Authorized		 No
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