The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Nrfit Epidural Needles.
| Device ID | K172823 |
| 510k Number | K172823 |
| Device Name: | Portex NRFit Epidural Needles |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Sunita Teekasingh |
| Correspondent | Sunita Teekasingh Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517079238 | K172823 | 000 |
| 35019517075759 | K172823 | 000 |
| 35019517075773 | K172823 | 000 |
| 55019517075807 | K172823 | 000 |
| 35019517075926 | K172823 | 000 |
| 35019517076480 | K172823 | 000 |
| 35019517078798 | K172823 | 000 |
| 35019517079139 | K172823 | 000 |
| 35019517079177 | K172823 | 000 |
| 35019517075742 | K172823 | 000 |