The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monojet Sps Blood Collection Tube.
| Device ID | K831719 |
| 510k Number | K831719 |
| Device Name: | MONOJET SPS BLOOD COLLECTION TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-31 |
| Decision Date | 1983-07-18 |