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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 K854750
Device Name TOP SUN
Applicant
WERNER SCHOTT ELEKTROGERATE
POSTFACH 1660 AM PFERDEMAK7 TI
3012 LANGENHAGEN 1
WEST GERMANY,  DE
Applicant Contact UNGRUH GMBLT
Correspondent
WERNER SCHOTT ELEKTROGERATE
POSTFACH 1660 AM PFERDEMAK7 TI
3012 LANGENHAGEN 1
WEST GERMANY,  DE
Correspondent Contact UNGRUH GMBLT
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/26/1985
Decision Date 02/14/1986
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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