The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Dd Ureteral Stent, Integral Stent.
| Device ID | K982974 |
| 510k Number | K982974 |
| Device Name: | DD URETERAL STENT, INTEGRAL STENT |
| Classification | Stent, Ureteral |
| 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 | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-25 |
| Decision Date | 1999-07-02 |
| Summary: | summary |