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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 K103783
Device Name EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
Applicant
Fiab Spa
Via Costoli, 4
Vicchio Florence,  IT 50039
Applicant Contact ALBERTO CALABRO
Correspondent
Fiab Spa
Via Costoli, 4
Vicchio Florence,  IT 50039
Correspondent Contact ALBERTO CALABRO
Regulation Number870.5300
Classification Product Code
LDD  
Date Received12/27/2010
Decision Date 06/16/2011
Decision Substantially Equivalent (SESE)
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
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