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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K964475
Device Name CLINICAL BLOOD GAS MIXTURES
Applicant
Oxarc, Inc.
716 S. Oregon Ave.
Pasco,  WA  99301
Applicant Contact TRAVIS AUGER
Correspondent
Oxarc, Inc.
716 S. Oregon Ave.
Pasco,  WA  99301
Correspondent Contact TRAVIS AUGER
Regulation Number862.1150
Classification Product Code
JIS  
Subsequent Product Code
CHL  
Date Received11/07/1996
Decision Date 12/06/1996
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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