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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 K904425
Device Name MODEL 6/01 UV-B FIXTURE
Applicant
STRATO-RAY CO.
6500 WALKER ST.
MINNEAPOLIS,  MN  55426
Applicant Contact DONALD GUSTAFSON
Correspondent
STRATO-RAY CO.
6500 WALKER ST.
MINNEAPOLIS,  MN  55426
Correspondent Contact DONALD GUSTAFSON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/27/1990
Decision Date 11/21/1990
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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