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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 K992965
Device Name CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
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 Received09/02/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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