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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 K853394
Device Name 600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L
Applicant
Interlab(Electromechanical)
24 Helenslea Ave.
London,Nw11 8nd, England,  GB
Applicant Contact BRAUNER
Correspondent
Interlab(Electromechanical)
24 Helenslea Ave.
London,Nw11 8nd, England,  GB
Correspondent Contact BRAUNER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/12/1985
Decision Date 09/13/1985
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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