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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K904868
Device Name XEMEX TEMPORARY PACING CATHETER A
Applicant
Zeon Medical Corp.
50 Main St.
White Plains,  NY  10606
Applicant Contact BURNS, JR.
Correspondent
Zeon Medical Corp.
50 Main St.
White Plains,  NY  10606
Correspondent Contact BURNS, JR.
Regulation Number870.3680
Classification Product Code
LDF  
Date Received10/29/1990
Decision Date 05/16/1991
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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