The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Mahler Abdominal Wall Elevator.
| Device ID | K960878 |
| 510k Number | K960878 |
| Device Name: | MAHLER ABDOMINAL WALL ELEVATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-04 |
| Decision Date | 1996-03-15 |
| Summary: | summary |