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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 K980503
Device Name TEMPORARY CARDIAC PACING WIRE
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact GREGORY R JONES
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact GREGORY R JONES
Regulation Number870.3680
Classification Product Code
LDF  
Date Received02/09/1998
Decision Date 04/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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