The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Monoject Arterial Blood Sampling Device.
| Device ID | K790196 |
| 510k Number | K790196 |
| Device Name: | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE |
| Classification | Arterial Blood Sampling Kit |
| Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-25 |
| Decision Date | 1979-03-13 |