The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Kit Pak's Flushing Kit.
| Device ID | K922051 |
| 510k Number | K922051 |
| Device Name: | KIT PAK'S FLUSHING KIT |
| Classification | Catheter, Urological |
| Applicant | KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
| Contact | Thomas J Sanders |
| Correspondent | Thomas J Sanders KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-01 |
| Decision Date | 1993-06-17 |