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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 K851408
Device Name SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER
Applicant
APPLIED SCIENCE, INC.
1800 S. MYRTLE AVE.
MONROVIA,  CA  91016
Applicant Contact JOHN F LAZEAR
Correspondent
APPLIED SCIENCE, INC.
1800 S. MYRTLE AVE.
MONROVIA,  CA  91016
Correspondent Contact JOHN F LAZEAR
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/09/1985
Decision Date 07/05/1985
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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