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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, pacemaker, temporary
510(k) Number K960479
Device Name ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
Original Applicant
ARROW INTL., INC.
3000 bernville rd.
reading,  PA  19605
Original Contact thomas d nickel
Regulation Number870.3680
Classification Product Code
LDF  
Date Received02/02/1996
Decision Date 10/17/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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