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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 K861989
Device Name MODIFICATION OF SUNTANA SUN SYSTEM BED
Applicant
Hawaiian Tan Spa
1219 Jordan Ln.
Huntsville,  AL  35816
Applicant Contact WALT WILLIAMON
Correspondent
Hawaiian Tan Spa
1219 Jordan Ln.
Huntsville,  AL  35816
Correspondent Contact WALT WILLIAMON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received05/23/1986
Decision Date 06/09/1986
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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