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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 K861705
Device Name CORONA 3000 (DERMATOLOGIC ULTRAVIOLET LAMP)
Applicant
VITA-TAN CORP.
1208 WEST 39TH ST.
KANSAS CITY,  MO  64111
Applicant Contact DONALD DEWIT
Correspondent
VITA-TAN CORP.
1208 WEST 39TH ST.
KANSAS CITY,  MO  64111
Correspondent Contact DONALD DEWIT
Regulation Number878.4630
Classification Product Code
FTC  
Date Received05/05/1986
Decision Date 05/16/1986
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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