The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Kendall Ultramer Coude Foley Catheter, Model 1416c, Kendall Curity Coude Foley Catheter Tray, Model 6946c.
| Device ID | K990500 |
| 510k Number | K990500 |
| Device Name: | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
| Contact | Paul W Evans |
| Correspondent | Paul W Evans THE KENDAL CO. 15 HAMPSHIRE ST. Mansfield, MA 02048 -1108 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-17 |
| Decision Date | 1999-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521016146 | K990500 | 000 |
| 30884521016969 | K990500 | 000 |
| 30884521015856 | K990500 | 000 |
| 30884521015825 | K990500 | 000 |
| 20884521015811 | K990500 | 000 |