The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Pakter Curved Needle Set.
| Device ID | K173155 |
| 510k Number | K173155 |
| Device Name: | Pakter Curved Needle Set |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Johnathan Liu |
| Correspondent | Johnathan Liu Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-06-07 |
| Summary: | summary |