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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K882941
Device Name BLOOD GAS MIXTURE
Applicant
Swisco, Inc.
P.O. Box 1563
Lake Charles,  LA  70602
Applicant Contact LEE PHILLIPS
Correspondent
Swisco, Inc.
P.O. Box 1563
Lake Charles,  LA  70602
Correspondent Contact LEE PHILLIPS
Regulation Number862.1120
Classification Product Code
CHL  
Date Received07/07/1988
Decision Date 09/09/1988
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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