The following data is part of a premarket notification filed by The Kendall Company Div. Of Tyco Healthcare Group with the FDA for Dover Silver Hydrogel Coated Silicone Foley Catheter.
| Device ID | K024010 |
| 510k Number | K024010 |
| Device Name: | DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521723372 | K024010 | 000 |
| 20884521723259 | K024010 | 000 |
| 10884521026599 | K024010 | 000 |
| 20884521026589 | K024010 | 000 |
| 10884521026575 | K024010 | 000 |
| 10884521026568 | K024010 | 000 |
| 10884521723412 | K024010 | 000 |
| 30884521723409 | K024010 | 000 |
| 10884521723399 | K024010 | 000 |
| 10884521723382 | K024010 | 000 |
| 20884521723266 | K024010 | 000 |
| 20884521723273 | K024010 | 000 |
| 10884521723368 | K024010 | 000 |
| 10884521723351 | K024010 | 000 |
| 10884521723344 | K024010 | 000 |
| 10884521723337 | K024010 | 000 |
| 20884521723327 | K024010 | 000 |
| 20884521723310 | K024010 | 000 |
| 10884521723306 | K024010 | 000 |
| 20884521723297 | K024010 | 000 |
| 10884521723283 | K024010 | 000 |
| 30884521026517 | K024010 | 000 |