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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K902749
Device Name OLYMPIC MINI BILI-LITE, MODEL 77
Applicant
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Applicant Contact KEN THOMAS
Correspondent
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Correspondent Contact KEN THOMAS
Regulation Number880.5700
Classification Product Code
LBI  
Date Received06/22/1990
Decision Date 08/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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