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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 K931660
Device Name ULTRABRONZ SERIES 400 TANNING BED
Applicant
Eurocut, Ltd.
365 Southridge Dr.
Agoura,  CA  91301
Applicant Contact PETER D MILLS
Correspondent
Eurocut, Ltd.
365 Southridge Dr.
Agoura,  CA  91301
Correspondent Contact PETER D MILLS
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received04/05/1993
Decision Date 12/17/1993
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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