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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arterial Blood Sampling Kit
510(k) Number K875117
Device Name CIBA CORNING BALANCED HEPARIN FOR CA++
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 Number868.1100
Classification Product Code
CBT  
Date Received12/15/1987
Decision Date 02/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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