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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 K854515
Device Name SHAW SUN SYSTEMS 1000, 2000 & 3200
Applicant
Shaw Sun Systems
Rt. 2 Box 216
Brookline,  MO  65619
Applicant Contact DONALD A SHAW
Correspondent
Shaw Sun Systems
Rt. 2 Box 216
Brookline,  MO  65619
Correspondent Contact DONALD A SHAW
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/12/1985
Decision Date 11/25/1985
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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