The following data is part of a premarket notification filed by Corpak Co. with the FDA for Urethral Cath. Tray W/bag.
| Device ID | K840292 |
| 510k Number | K840292 |
| Device Name: | URETHRAL CATH. TRAY W/BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | CORPAK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-03-16 |