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 |