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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 K853833
Device Name TOP SUN MODELS 100,101,103 &139, 139-1, 139-3
Applicant
TOP SUN AMERICA, INC.
6227 VANCE RD. STE 8
CHATTANOOGA,  TN  37421
Applicant Contact LARRY N YELVERTON
Correspondent
TOP SUN AMERICA, INC.
6227 VANCE RD. STE 8
CHATTANOOGA,  TN  37421
Correspondent Contact LARRY N YELVERTON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/16/1985
Decision Date 10/24/1985
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
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