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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 K895533
Device Name LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER
Applicant
Matrix Medica, Inc.
145 Mid County Dr.
Orchard Park,  NY 
Applicant Contact WYNNE, P.E.
Correspondent
Matrix Medica, Inc.
145 Mid County Dr.
Orchard Park,  NY 
Correspondent Contact WYNNE, P.E.
Regulation Number870.5300
Classification Product Code
LDD  
Date Received09/13/1989
Decision Date 01/26/1990
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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