FDA 510(k) Application Details - K955722

Device Classification Name Electrode, Pacemaker, Temporary

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510(K) Number K955722
Device Name Electrode, Pacemaker, Temporary
Applicant DAVIS & GECK, INC.
ONE CASPER ST.
DANBURY, CT 06810 US
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Contact STEPHEN J TAMSETT
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Regulation Number 870.3680

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Classification Product Code LDF
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Date Received 12/18/1995
Decision Date 03/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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