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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K142414
Device Name Miltex N-Tralig Intraligamentary Syringe
Applicant
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact Judith E. O'Grady
Correspondent
Integra LifeSciences Corporation
589 Davies Dr.
York,  PA  17402
Correspondent Contact Ruthanne Vendy
Regulation Number872.6770
Classification Product Code
EJI  
Date Received08/28/2014
Decision Date 10/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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