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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 K860566
Device Name NORDIC SUN 24 LAMP TANNING BED
Applicant
NORDIC SUN CORPORATION OF AMERICA
2770 SUMMER ST.
STAMFORD,  CT  06905
Applicant Contact ADRIAN WERNER
Correspondent
NORDIC SUN CORPORATION OF AMERICA
2770 SUMMER ST.
STAMFORD,  CT  06905
Correspondent Contact ADRIAN WERNER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/14/1986
Decision Date 03/05/1986
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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