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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K052465
Device Name REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
Original Applicant
HEARTSINE TECHNOLOGIES, INC.
105 terry dr
newtown,  PA  18940
Original Contact george brdlik
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/08/2005
Decision Date 12/12/2006
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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