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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
Applicant
Heartsine Technologies, Inc.
105 Terry Dr.
Newtown,  PA  18940
Applicant Contact GEORGE BRDLIK
Correspondent
Heartsine Technologies, Inc.
105 Terry Dr.
Newtown,  PA  18940
Correspondent Contact GEORGE BRDLIK
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/08/2005
Decision Date 12/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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