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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 K013896
Device Name SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA
Applicant
Defibtech, LLC
1200 Boston Post Rd.
Suite 207
Guilford,  CT  06437
Applicant Contact GINTARAS VAISNYS
Correspondent
Defibtech, LLC
1200 Boston Post Rd.
Suite 207
Guilford,  CT  06437
Correspondent Contact GINTARAS VAISNYS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received11/23/2001
Decision Date 06/19/2002
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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