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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light, ultraviolet, dermatological
510(k) Number K896191
Device Name SUNTANNING BED, INC. T12 UVA TANNING LAMPS
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 Number878.4630
Classification Product Code
FTC  
Date Received10/26/1989
Decision Date 12/27/1989
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
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