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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 K850660
Device Name SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY
Applicant
Suntech USA, Inc.
1850 S. Main
South Jacksonville,  IL  62650
Applicant Contact LUDGER STEIN
Correspondent
Suntech USA, Inc.
1850 S. Main
South Jacksonville,  IL  62650
Correspondent Contact LUDGER STEIN
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/20/1985
Decision Date 03/01/1985
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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