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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name permanent pacemaker electrode
510(k) Number K864002
Device Name MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD
Original Applicant
INTERMEDICS, INC.
p.o. box 617
freeport,  TX  77541 -0617
Original Contact ken bishop
Regulation Number870.3680
Classification Product Code
DTB  
Date Received10/14/1986
Decision Date 11/20/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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