The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Miltex N-tralig Intraligamentary Syringe.
| Device ID | K142414 |
| 510k Number | K142414 |
| Device Name: | Miltex N-Tralig Intraligamentary Syringe |
| Classification | Syringe, Cartridge |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Judith E. O'grady |
| Correspondent | Ruthanne Vendy INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2014-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H8347655SS1 | K142414 | 000 |
| 10381780369134 | K142414 | 000 |
| 10381780369127 | K142414 | 000 |
| H834PN3SS1 | K142414 | 000 |
| H834PN2SS1 | K142414 | 000 |
| H8347655MSS1 | K142414 | 000 |
| 10381780174875 | K142414 | 000 |
| 10381780174868 | K142414 | 000 |
| 10381780532422 | K142414 | 000 |