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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
510(k) Number K862114
Device Name KHURI REGIONAL TISSUE PH MONITOR
Applicant
Vascular Technology Incorporated
Medical Device Consultants,Inc
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact JAMES R VEALE
Correspondent
Vascular Technology Incorporated
Medical Device Consultants,Inc
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact JAMES R VEALE
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received06/03/1986
Decision Date 06/25/1986
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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