The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Kish Urethral Illuminated Catheter Set.
| Device ID | K810367 |
| 510k Number | K810367 |
| Device Name: | KISH URETHRAL ILLUMINATED CATHETER SET |
| Classification | Catheter, Urological |
| Applicant | VANCE PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-12 |
| Decision Date | 1981-03-20 |