The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Curity 100% Silicone Coude' Catheter.
| Device ID | K833790 |
| 510k Number | K833790 |
| Device Name: | CURITY 100% SILICONE COUDE' CATHETER |
| Classification | Catheter, Urological |
| Applicant | THE KENDAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-31 |
| Decision Date | 1983-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521015968 | K833790 | 000 |
| 30884521015924 | K833790 | 000 |
| 20884521015941 | K833790 | 000 |
| 20884521015958 | K833790 | 000 |
| 30884521015986 | K833790 | 000 |
| 20884521016009 | K833790 | 000 |
| 30884521016013 | K833790 | 000 |
| 30884521016020 | K833790 | 000 |
| 20884521016030 | K833790 | 000 |
| 30884521016068 | K833790 | 000 |
| 30884521016099 | K833790 | 000 |
| 30884521016105 | K833790 | 000 |
| 20192253024194 | K833790 | 000 |