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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 K862372
Device Name ULTRATAN TANNING SYSTEM
Applicant
HEALTH SYSTEMS INTL., INC.
4230 GROVE AVE.
GURNEE,  IL  60031
Applicant Contact JOHN B SPENCER
Correspondent
HEALTH SYSTEMS INTL., INC.
4230 GROVE AVE.
GURNEE,  IL  60031
Correspondent Contact JOHN B SPENCER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/24/1986
Decision Date 07/09/1986
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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