The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Suprapubic Tray.
| Device ID | K970021 |
| 510k Number | K970021 |
| Device Name: | RUSCH SUPRAPUBIC TRAY |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Karenann J Brozowski |
| Correspondent | Karenann J Brozowski RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-03 |
| Decision Date | 1997-02-07 |
| Summary: | summary |