The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Tamponade Uterine Balloon Catheter Set.
| Device ID | K013597 |
| 510k Number | K013597 |
| Device Name: | TAMPONADE UTERINE BALLOON CATHETER SET |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Cindy Rumple |
| Correspondent | Cindy Rumple COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-31 |
| Decision Date | 2002-04-17 |
| Summary: | summary |