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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 K852579
Device Name THE SUNTANNING CO. TANNING BED
Applicant
The Suntanning Company, Inc.
1000s. Caraway, Su 103
Jonesboro,  AR  72401
Applicant Contact DAN MCKENNEY
Correspondent
The Suntanning Company, Inc.
1000s. Caraway, Su 103
Jonesboro,  AR  72401
Correspondent Contact DAN MCKENNEY
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/18/1985
Decision Date 07/03/1985
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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