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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 K913521
Device Name XEMEX TEMPORARY PACING CATHETER A MODIFIED
Applicant
Zeon Medical Corp.
50 Main St.
White Plains,  NY  10606
Applicant Contact ROBERT BURNS
Correspondent
Zeon Medical Corp.
50 Main St.
White Plains,  NY  10606
Correspondent Contact ROBERT BURNS
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/06/1991
Decision Date 12/27/1991
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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