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510(k) Premarket Notification Database

Device Classification Name electrode, pacemaker, permanent
510(k) NumberK955550
Device NameCARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
Applicant
INTERMEDICS, INC.
4000 technology dr.
angleton,  TX  77515
Contactlori kleinschrodt holder
Regulation Number870.3680
Classification Product Code
DTB
Date Received12/05/1995
Decision Date 06/19/1996
Decision se subject to tracking reg (ST)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 02/06/2009

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