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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 K955829
Device Name SAFPACE SYSTEM
Original Applicant
B. BRAUN MEDICAL, INC.
824 twelfth ave.
bethlehem,  PA  18018
Original Contact mark s alsberge
Regulation Number870.3680
Classification Product Code
LDF  
Date Received12/26/1995
Decision Date 11/18/1997
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
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