The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch International Urodynamic Catheters.
| Device ID | K952029 |
| 510k Number | K952029 |
| Device Name: | RUSCH INTERNATIONAL URODYNAMIC CATHETERS |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil Armstrong |
| Correspondent | Neil Armstrong RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-06-13 |