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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 K093327
Device Name INTCO TAB ELECTRODE
Applicant
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
814 AIRPORT WAY
SANDPOINT,  ID  83864
Applicant Contact CHRIS HEALY
Correspondent
SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD.
814 AIRPORT WAY
SANDPOINT,  ID  83864
Correspondent Contact CHRIS HEALY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/26/2009
Decision Date 05/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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