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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K964469
Device Name 700-F SERIES STIMULATION ELECTRODES
Applicant
CARDIOTRONICS SYSTEMS, INC.
5966 LA PLACE CT.
CARLSBAD,  CA  92008
Applicant Contact TIM J WAY
Correspondent
CARDIOTRONICS SYSTEMS, INC.
5966 LA PLACE CT.
CARLSBAD,  CA  92008
Correspondent Contact TIM J WAY
Regulation Number870.5300
Classification Product Code
LDD  
Date Received11/07/1996
Decision Date 12/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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