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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 K936314
Device Name ODYSSEY TAN 2000
Applicant
Fitness TO Go, Inc.
4251 NE Port Dr.
Lees Summit,  MO  64064
Applicant Contact JAMES RUSSELL
Correspondent
Fitness TO Go, Inc.
4251 NE Port Dr.
Lees Summit,  MO  64064
Correspondent Contact JAMES RUSSELL
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received12/20/1993
Decision Date 07/22/1994
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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