The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Lawson Retrograde Nephrostomy Wire Puncture Set.
| Device ID | K190903 |
| 510k Number | K190903 |
| Device Name: | Lawson Retrograde Nephrostomy Wire Puncture Set |
| Classification | Catheter, Nephrostomy |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Andrew Breidenbach |
| Correspondent | Andrew Breidenbach Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-08 |
| Decision Date | 2019-12-16 |