The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Sympacath Hydrogel Coated Foley.
| Device ID | K964575 |
| 510k Number | K964575 |
| Device Name: | SYMPACATH HYDROGEL COATED FOLEY |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Karenann J Brozowski |
| Correspondent | Karenann J Brozowski RUSCH INTL. 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 | 1996-11-14 |
| Decision Date | 1997-02-04 |
| Summary: | summary |