The following data is part of a premarket notification filed by Kleen Test Products with the FDA for Needle Counter-sure Count/10 Count.
| Device ID | K801258 |
| 510k Number | K801258 |
| Device Name: | NEEDLE COUNTER-SURE COUNT/10 COUNT |
| Classification | Calibrator, Pressure, Gas |
| Applicant | KLEEN TEST PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BXX |
| CFR Regulation Number | 868.2620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-28 |
| Decision Date | 1980-06-04 |