The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Dover Red Rubber Robinson Catheter.
| Device ID | K041243 |
| 510k Number | K041243 |
| Device Name: | DOVER RED RUBBER ROBINSON 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 | 2004-05-11 |
| Decision Date | 2004-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521030484 | K041243 | 000 |
| 20884521030470 | K041243 | 000 |
| 30884521030460 | K041243 | 000 |
| 30884521019830 | K041243 | 000 |
| 30884521019823 | K041243 | 000 |