The following data is part of a premarket notification filed by Tfx Medical, Inc. with the FDA for Modified Tfx Medical Safety Needle With Introducer.
| Device ID | K021034 |
| 510k Number | K021034 |
| Device Name: | MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | TFX MEDICAL, INC. 50 PLANTATION DR. Jaffrey, NH 03452 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins TFX MEDICAL, INC. 50 PLANTATION DR. Jaffrey, NH 03452 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-06-26 |
| Summary: | summary |