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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K102430
Device Name TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
Applicant
Tyco Electronics Corporation
10025 SW Freeman Ct.
Wilsonville,  OR  97070
Applicant Contact DENNIS M GILKEY
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact DAWN TIBODEAU
Regulation Number870.2900
Classification Product Code
DSA  
Date Received08/26/2010
Decision Date 09/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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