The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Patton Laparoscopic Catheter Introducer Set.
| Device ID | K940265 |
| 510k Number | K940265 |
| Device Name: | PATTON LAPAROSCOPIC CATHETER INTRODUCER SET |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Darcy Job |
| Correspondent | Darcy Job COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1995-09-28 |