The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Kendall Curity & Kenguard Red Rubber Urethral Cath.
| Device ID | K881667 |
| 510k Number | K881667 |
| Device Name: | KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH |
| Classification | Catheter, Urethral |
| Applicant | THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Contact | Jane R Arnold |
| Correspondent | Jane R Arnold 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 | 1988-04-18 |
| Decision Date | 1988-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521017003 | K881667 | 000 |
| 30884521019748 | K881667 | 000 |
| 20884521019734 | K881667 | 000 |
| 20884521019727 | K881667 | 000 |
| 30884521019717 | K881667 | 000 |
| 20884521019703 | K881667 | 000 |
| 20884521019697 | K881667 | 000 |
| 30884521019687 | K881667 | 000 |
| 20884521019673 | K881667 | 000 |