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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 K982415
Device Name CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
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 Received07/13/1998
Decision Date 08/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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