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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 K113787
Device Name DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
Applicant
DEFIBTECH, LLC
741 boston post road
guilford,  CT  06437
Applicant Contact ed horton
Correspondent
DEFIBTECH, LLC
741 boston post road
guilford,  CT  06437
Correspondent Contact ed horton
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/22/2011
Decision Date 01/04/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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