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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 K875190
Device Name ULTRA TAN PURPLE PRO
Applicant
Ultra Tan Intl. AB
Box 80
S-598 00 Vimmerby
Sweden,  SE
Applicant Contact SUNE GEGERFELT
Correspondent
Ultra Tan Intl. AB
Box 80
S-598 00 Vimmerby
Sweden,  SE
Correspondent Contact SUNE GEGERFELT
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received12/17/1987
Decision Date 01/14/1988
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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