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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 Pl. Ct.
Carlsbad,  CA  92008
Applicant Contact TIM J WAY
Correspondent
Cardiotronics Systems, Inc.
5966 La Pl. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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