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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, electrode recording, or probe, electrode recording
510(k) Number K953768
Device Name CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
Applicant
CORDIS WEBSTER, INC.
4750 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Applicant Contact MARY ADAMS
Correspondent
CORDIS WEBSTER, INC.
4750 LITTLEJOHN ST.
BALDWIN PARK,  CA  91706
Correspondent Contact MARY ADAMS
Regulation Number870.1220
Classification Product Code
DRF  
Date Received08/14/1995
Decision Date 11/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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