The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Floneil; Flocath Introgel.
| Device ID | K020714 |
| 510k Number | K020714 |
| Device Name: | RUSCH FLONEIL; FLOCATH INTROGEL |
| Classification | Catheter, Urethral |
| 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 | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-05 |
| Decision Date | 2002-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704331145 | K020714 | 000 |
| 44026704325366 | K020714 | 000 |
| 44026704325373 | K020714 | 000 |
| 44026704325380 | K020714 | 000 |
| 44026704325397 | K020714 | 000 |
| 44026704325403 | K020714 | 000 |
| 44026704331107 | K020714 | 000 |
| 44026704331114 | K020714 | 000 |
| 44026704331121 | K020714 | 000 |
| 44026704331138 | K020714 | 000 |
| 44026704325359 | K020714 | 000 |