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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 K853679
Device Name SUNJET MODELS 240/280
Applicant
Sunjet Manufacturer, Inc.
2706 Ogden Rd.
Roanoke,  VA  24014
Applicant Contact CHARLES F DAVIS
Correspondent
Sunjet Manufacturer, Inc.
2706 Ogden Rd.
Roanoke,  VA  24014
Correspondent Contact CHARLES F DAVIS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/04/1985
Decision Date 10/01/1985
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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