The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Kendall Curity Urethral Catheters.
| Device ID | K892442 |
| 510k Number | K892442 |
| Device Name: | KENDALL CURITY URETHRAL CATHETERS |
| Classification | Catheter, Urethral |
| Applicant | THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Contact | William D Curtin |
| Correspondent | William D Curtin THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-06-23 |