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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 K873474
Device Name SUTURELESS TEMPORARY EPICARDIAL PACING LEAD
Applicant
Symbion, Inc.
350 W. 800 N.
Salt Lake City,  UT  84103
Applicant Contact RICK GAYKOWSKI
Correspondent
Symbion, Inc.
350 W. 800 N.
Salt Lake City,  UT  84103
Correspondent Contact RICK GAYKOWSKI
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/31/1987
Decision Date 10/07/1987
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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