The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Silicone Foley Catheter.
| Device ID | K980870 |
| 510k Number | K980870 |
| Device Name: | RUSCH SILICONE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | James R Whitney |
| Correspondent | James R Whitney RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-04 |
| Decision Date | 1998-06-09 |
| Summary: | summary |