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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Booth, Sun Tan
510(k) Number K801520
Device Name SOLAR PACIFIC UVA SUNLAMP DEVICE
Applicant
Solar Pacific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Solar Pacific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received07/01/1980
Decision Date 08/20/1980
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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