The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Dover Rob-nel Catheter.
| Device ID | K040897 |
| 510k Number | K040897 |
| Device Name: | DOVER ROB-NEL CATHETER |
| Classification | Catheter, Urological |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Wei Zhao |
| Correspondent | Wei Zhao TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-06 |
| Decision Date | 2004-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521009094 | K040897 | 000 |
| 20884521009087 | K040897 | 000 |
| 20884521009070 | K040897 | 000 |
| 20884521009056 | K040897 | 000 |
| 20884521009049 | K040897 | 000 |
| 20884521009032 | K040897 | 000 |