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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, Phototherapy (Puva)
510(k) Number K852575
Device Name WALDMANN F85/100W PUVA
Applicant
Sylvania Lighting Products
100 Endicott St.
Danvers,  MA  01923
Applicant Contact GWARREN J FIELD
Correspondent
Sylvania Lighting Products
100 Endicott St.
Danvers,  MA  01923
Correspondent Contact GWARREN J FIELD
Regulation Number878.4630
Classification Product Code
KGL  
Date Received06/18/1985
Decision Date 08/16/1985
Decision Substantially Equivalent - With Drug (SESD)
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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