The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Polyflex Stent For The Esophagus With Introducer System.
| Device ID | K010068 |
| 510k Number | K010068 |
| Device Name: | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM |
| Classification | Prosthesis, Esophageal |
| Applicant | RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Contact | Karenann J Brozowski |
| Correspondent | Karenann J Brozowski RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-08 |
| Decision Date | 2001-02-08 |