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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 K903948
Device Name INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
Applicant
INTERMEDICS, INC.
p.o. box 617
freeport,  TX  77541 0617
Contact kathleen m chester
Regulation Number870.3680
Classification Product Code
DTB  
Date Received08/27/1990
Decision Date 04/22/1991
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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