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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 K863937
Device Name OSRAM ULTRAMED 400 W
Applicant
Osram GmbH
Postfach 90 06 20
D-8000 Munchen 90
West Germany,  DE
Applicant Contact DOBIASCH
Correspondent
Osram GmbH
Postfach 90 06 20
D-8000 Munchen 90
West Germany,  DE
Correspondent Contact DOBIASCH
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/09/1986
Decision Date 11/04/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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