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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 K020984
Device Name ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
Applicant
ACCESS CARDIOSYSTEMS, INC.
150 BAKER AVENUE EXTENSION
SUITE 108
CONCORD,  MA  01742
Applicant Contact DAVID BARASH
Correspondent
ACCESS CARDIOSYSTEMS, INC.
150 BAKER AVENUE EXTENSION
SUITE 108
CONCORD,  MA  01742
Correspondent Contact DAVID BARASH
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
LDD  
Date Received03/18/2002
Decision Date 08/14/2002
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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