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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 K895325
Device Name SUNTANNING BED
Applicant
Sunbronze
4510 Woodson Rd.
St. Louis,  MO  63134
Applicant Contact DAN GAUTHIER
Correspondent
Sunbronze
4510 Woodson Rd.
St. Louis,  MO  63134
Correspondent Contact DAN GAUTHIER
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received08/29/1989
Decision Date 09/15/1989
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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