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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 K033896
Device Name DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
Applicant
DEFIBTECH, LLC
753 BOSTON POST RD., SUITE 102
GUILFORD,  CT  06437
Applicant Contact JOHN L ROGERS
Correspondent
DEFIBTECH, LLC
753 BOSTON POST RD., SUITE 102
GUILFORD,  CT  06437
Correspondent Contact JOHN L ROGERS
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received12/16/2003
Decision Date 06/16/2004
Decision Substantially Equivalent (SESE)
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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