The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Curity & Kenguard Silicone Coated Foley Catheter.
| Device ID | K860484 |
| 510k Number | K860484 |
| Device Name: | CURITY & KENGUARD SILICONE COATED FOLEY CATHETER |
| Classification | Catheter, Urological |
| Applicant | THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Contact | Christine Morgida |
| Correspondent | Christine Morgida THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-10 |
| Decision Date | 1986-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521019867 | K860484 | 000 |
| 20884521030951 | K860484 | 000 |
| 30884521019847 | K860484 | 000 |