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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 K090180
Device Name TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
Applicant
Vermed, Inc.
9 Lovell Dr.
Bellows Falls,  VT  05101
Applicant Contact MARC FILLION
Correspondent
Vermed, Inc.
9 Lovell Dr.
Bellows Falls,  VT  05101
Correspondent Contact MARC FILLION
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/23/2009
Decision Date 06/17/2009
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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