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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
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