Miltex N-Tralig Intraligamentary Syringe
FDA 510(k) K142414 · Integra LifeSciences Corporation
510(k) numberK142414
Submission
- Device name
- Miltex N-Tralig Intraligamentary Syringe
- Applicant
- Integra LifeSciences Corporation
Planisboro, NJ, US - Received
- August 28, 2014
- Decision date
- October 30, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Miltex N-Tralig Intraligamentary Syringe cleared by the FDA?
Miltex N-Tralig Intraligamentary Syringe (K142414) received a 510(k) decision of Substantially Equivalent on October 30, 2014, 63 days after the submission was received.
What is the product code of K142414?
The FDA product code is EJI – Syringe, Cartridge, a Class II (moderate risk) device regulated under 21 CFR 872.6770.