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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 K862263
Device Name PERSUNAL TAN, MODEL NO. HU-0208L
Applicant
SUNTHETIC ENGINEERING, INC.
320 35TH ST.
MARION,  IA  52302
Applicant Contact RICK KASPAREK
Correspondent
SUNTHETIC ENGINEERING, INC.
320 35TH ST.
MARION,  IA  52302
Correspondent Contact RICK KASPAREK
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/13/1986
Decision Date 06/20/1986
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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