The following data is part of a premarket notification filed by Tfx Medical, Inc. with the FDA for Tfx Medical Safety Needle With Introducer.
| Device ID | K000665 |
| 510k Number | K000665 |
| Device Name: | TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | TFX MEDICAL, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Karenann J Brozowski |
| Correspondent | Karenann J Brozowski TFX MEDICAL, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-05-02 |