The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Lehman Manometry Catheter.
| Device ID | K160170 |
| 510k Number | K160170 |
| Device Name: | Lehman Manometry Catheter |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Doris A. Hawks |
| Correspondent | Doris A. Hawks Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-06-20 |
| Summary: | summary |