The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monojet Samplette Adapters.
| Device ID | K832578 |
| 510k Number | K832578 |
| Device Name: | MONOJET SAMPLETTE ADAPTERS |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-08-31 |