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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Pasteurization, Hot Water
510(k) Number K972193
Device Name OLYMPIX MINI-PASTEURMATIC (58210)
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 Number880.6991
Classification Product Code
LDS  
Date Received06/10/1997
Decision Date 09/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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