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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 K932418
Device Name SUNBRONZE TANNING LAMPS
Applicant
Ess Lighting
5830 Fee Fee Rd.
Hazelwood,  MO  63042
Applicant Contact DAN GAUTHIER
Correspondent
Ess Lighting
5830 Fee Fee Rd.
Hazelwood,  MO  63042
Correspondent Contact DAN GAUTHIER
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received05/18/1993
Decision Date 12/09/1993
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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