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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K843530
Device Name CORNING 614 NA/K ANALYZER
Applicant
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Applicant Contact William J Pignato
Correspondent
Corning Medical & Scientific
Corning Glass Works
Medfield,  MA  02052
Correspondent Contact William J Pignato
Regulation Number862.1665
Classification Product Code
JGS  
Date Received09/07/1984
Decision Date 12/11/1984
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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