The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Urodynamic Rectal Balloon 2-way Catheter.
| Device ID | K962472 |
| 510k Number | K962472 |
| Device Name: | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-25 |
| Decision Date | 1996-08-27 |
| Summary: | summary |