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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K954434
Device Name OLYMPIC INFANT THERMOMETER
Applicant
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Applicant Contact JOSEPH P STEFANILE
Correspondent
Olympic Medical Corp.
5900 First Ave. S.
Seattle,  WA  98108
Correspondent Contact JOSEPH P STEFANILE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/25/1995
Decision Date 12/20/1995
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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