The following data is part of a premarket notification filed by Tfx Medical Group with the FDA for Tfx Medical Introducer Kit.
| Device ID | K991647 |
| 510k Number | K991647 |
| Device Name: | TFX MEDICAL INTRODUCER KIT |
| Classification | Introducer, Catheter |
| Applicant | TFX MEDICAL GROUP TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Julie A Beaumont |
| Correspondent | Julie A Beaumont TFX MEDICAL GROUP TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-13 |
| Decision Date | 2000-01-04 |
| Summary: | summary |