The following data is part of a premarket notification filed by Kleen Test Products with the FDA for Kleen Test Basin Set.
| Device ID | K890039 |
| 510k Number | K890039 |
| Device Name: | KLEEN TEST BASIN SET |
| Classification | Catheter And Tip, Suction |
| Applicant | KLEEN TEST PRODUCTS P.O. BOX 140 Elkhorn, WI 53121 |
| Contact | Gary L Swanson |
| Correspondent | Gary L Swanson KLEEN TEST PRODUCTS P.O. BOX 140 Elkhorn, WI 53121 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-10 |
| Decision Date | 1989-10-24 |