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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauge, Pressure, Coronary, Cardiopulmonary Bypass
510(k) Number K944764
Device Name VTI DISPOSABLE PRESSURE DISPLAY SET
Applicant
Vascular Technology Incorporated
25 Industrial Ave.
Chelmsford,  MA  01824
Applicant Contact DAVID L REGAN
Correspondent
Vascular Technology Incorporated
25 Industrial Ave.
Chelmsford,  MA  01824
Correspondent Contact DAVID L REGAN
Regulation Number870.4310
Classification Product Code
DXS  
Date Received09/27/1994
Decision Date 12/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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