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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 K850493
Device Name SUNSHOWER MODEL HU-01-12L
Applicant
Sunthetic Engineering, Inc.
320 35th St.
Marion,  IA  52302
Applicant Contact DEAN MONTOUR
Correspondent
Sunthetic Engineering, Inc.
320 35th St.
Marion,  IA  52302
Correspondent Contact DEAN MONTOUR
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/08/1985
Decision Date 02/28/1985
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
Predetermined Change
Control Plan Authorized		 No
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