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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K791793
Device Name USCI PRESSURE GAUGE
Applicant
C.R. BARD, INC.
12 ELIZABETH DR.
CHELMSFORD,  MA  01824
Correspondent
C.R. BARD, INC.
12 ELIZABETH DR.
CHELMSFORD,  MA  01824
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/14/1979
Decision Date 12/11/1979
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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