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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 K911402
Device Name MODEL #350 SHOCK-PLATE DEFIB ADAPTOR
Applicant
CARDIOTRONICS, INC.
2726 LOKER AVE.
WEST CARLSBAD,  CA  92008
Applicant Contact TIM J WAY
Correspondent
CARDIOTRONICS, INC.
2726 LOKER AVE.
WEST CARLSBAD,  CA  92008
Correspondent Contact TIM J WAY
Regulation Number870.5300
Classification Product Code
LDD  
Date Received03/29/1991
Decision Date 10/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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