The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Modified Tfx Medical Safety Needle With Introducer, Part No. T4634-02.
| Device ID | K043258 |
| 510k Number | K043258 |
| Device Name: | MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | TELEFLEX MEDICAL 50 PLANTATION DRIVE TALL PINES PARK Jaffery, NH 03452 |
| Contact | Susan Kagan |
| Correspondent | Susan Kagan TELEFLEX MEDICAL 50 PLANTATION DRIVE TALL PINES PARK Jaffery, NH 03452 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-24 |
| Decision Date | 2004-12-16 |
| Summary: | summary |