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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 K781002
Device Name TEMPORARY CARDIAC PACING WIRE
Original Applicant
ETHICON, INC.
Regulation Number870.3680
Classification Product Code
LDF  
Date Received06/15/1978
Decision Date 12/04/1978
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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