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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ph Meter
510(k) Number K872888
Device Name CIBA CORNING 288 PH/BLOOD GAS SYSTEM
Applicant
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Applicant Contact William J Pignato
Correspondent
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Correspondent Contact William J Pignato
Regulation Number862.2050
Classification Product Code
JQY  
Date Received07/23/1987
Decision Date 08/25/1987
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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