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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. STE. L
ROCKAWAY,  NJ  07866
Applicant Contact NICK MENDISE
Correspondent
CARDIO MEDICAL PRODUCTS, INC.
385 FRANKLIN AVE. STE. 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
Recalls CDRH Recalls
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