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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement
510(k) Number K121173
Model CX-2012S,2038S,3012S,3038S
Device Name CHORD-X EPTFE SUTURE
Original Applicant
ON-XLIFETECHNOLOGIES
1300 east anderson lane
bldg b
austin,  TX  78752
Original Contact john ely
Regulation Number878.5035
Classification Product Code
PAW  
Date Received04/17/2012
Decision Date 08/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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