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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K953005
Device Name BILI-METER
Applicant
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Applicant Contact JOSEPH STEFANILE
Correspondent
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Correspondent Contact JOSEPH STEFANILE
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/28/1995
Decision Date 09/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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