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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 K082090
Device Name 9131 DEFIBRILLATION ELECTRODES
Applicant
CARDIAC SCIENCE CORPORATION
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021
Applicant Contact BEVERLY MAGRANE
Correspondent
CARDIAC SCIENCE CORPORATION
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021
Correspondent Contact BEVERLY MAGRANE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/24/2008
Decision Date 12/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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