FDA 510(k) Application Details - K955712

Device Classification Name Electrode, Pacemaker, Temporary

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510(K) Number K955712
Device Name Electrode, Pacemaker, Temporary
Applicant C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
BILLERICA, MA 01821 US
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Contact JANET D BENSON
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Regulation Number 870.3680

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Classification Product Code LDF
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Date Received 12/15/1995
Decision Date 10/11/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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