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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K092389
Device Name DISPOSAL ECG ELECTRODES, MODEL EASYRODE
Applicant
Suzuken Co., Ltd.
3f 2-17-6 Akebono-Cho
Tachikawa-Shi, Tokyo,  JP 190-0012
Applicant Contact KOJI KUBO
Correspondent
Suzuken Co., Ltd.
3f 2-17-6 Akebono-Cho
Tachikawa-Shi, Tokyo,  JP 190-0012
Correspondent Contact KOJI KUBO
Regulation Number870.2360
Classification Product Code
DRX  
Date Received08/05/2009
Decision Date 10/13/2009
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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