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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 K103159
Device Name CARDIO MED MODEL A102, H104, O101, P103, AND Z100
Applicant
Cardio Medical Products, Inc.
385 Franklin Ave. Suite L
Rockaway,  NJ  07866
Applicant Contact NICK MENDISE
Correspondent
Cardio Medical Products, Inc.
385 Franklin Ave. Suite L
Rockaway,  NJ  07866
Correspondent Contact NICK MENDISE
Regulation Number870.5300
Classification Product Code
LDD  
Date Received10/26/2010
Decision Date 01/11/2011
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
Recalls CDRH Recalls
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