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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 K852149
Device Name PORTASUN MODEL 600/LI SUNLAMP
Applicant
PORTASUN LTD.
24 HELENSLEA AVENUE
NW11 8ND
LONDON ENGLAND,  GB
Applicant Contact BRAUNER
Correspondent
PORTASUN LTD.
24 HELENSLEA AVENUE
NW11 8ND
LONDON ENGLAND,  GB
Correspondent Contact BRAUNER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received05/17/1985
Decision Date 05/31/1985
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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