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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 K873728
Device Name DEKNATEL TEMPORARY CARDIAC PACING WIRE
Applicant
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact OROFINO
Correspondent
Deknatel, Inc.
2300 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact OROFINO
Regulation Number870.3680
Classification Product Code
LDF  
Date Received09/16/1987
Decision Date 11/03/1987
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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