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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 K904644
Device Name EUROSUN MODELS - ES-2400, ES-VHO AND ES-16
Applicant
Eurosun, Inc.
921 Sixth Ave.
Huntington,  WV  25701
Applicant Contact DEAN DICKSON
Correspondent
Eurosun, Inc.
921 Sixth Ave.
Huntington,  WV  25701
Correspondent Contact DEAN DICKSON
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received10/11/1990
Decision Date 12/28/1990
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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