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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 K042088
Device Name SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
Applicant
HEARTSINE TECHNOLOGIES, INC.
940 CALLE AMANECER, SUITE E
SAN CLEMENTE,  CA  92673
Applicant Contact WILLIAM J SMIRLES
Correspondent
HEARTSINE TECHNOLOGIES, INC.
940 CALLE AMANECER, SUITE E
SAN CLEMENTE,  CA  92673
Correspondent Contact WILLIAM J SMIRLES
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received08/03/2004
Decision Date 09/02/2004
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
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