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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Catheter
510(k) Number K131446
Device Name INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
Applicant
Integra LifeSciences Corporation
589 Davies Dr.
York,  PA  17402
Applicant Contact STEPHANIE N SHEESLEY
Correspondent
Integra LifeSciences Corporation
589 Davies Dr.
York,  PA  17402
Correspondent Contact STEPHANIE N SHEESLEY
Regulation Number870.1300
Classification Product Code
DQR  
Date Received05/20/2013
Decision Date 10/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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