510(k) K142414
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