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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 K832794
Device Name SUNTANNING BOOTHS AND BEDS
Applicant
Tan-N-Trim
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Tan-N-Trim
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/09/1983
Decision Date 01/27/1984
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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