The following data is part of a premarket notification filed by C. B. Dumont Company, Inc. with the FDA for Henke Disposable Syringe.
| Device ID | K821537 |
| 510k Number | K821537 |
| Device Name: | HENKE DISPOSABLE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | C. B. DUMONT COMPANY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-24 |
| Decision Date | 1982-05-28 |