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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K823357
Device Name VARIOUS CARDIOVASCULAR PRODUCTS
Applicant
C.R. BARD, INC.
110 MARSHALL DRIVE
WARRANDALE,  PA  15086
Correspondent
C.R. BARD, INC.
110 MARSHALL DRIVE
WARRANDALE,  PA  15086
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/05/1982
Decision Date 03/11/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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