510(k) K142414

Miltex N-Tralig Intraligamentary Syringe by Integra LifeSciences Corporation — Product Code EJI

K142414 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "Miltex N-Tralig Intraligamentary Syringe". The FDA issued a decision of Substantially Equivalent on October 30, 2014. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2014
Date Received
August 28, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type