The following data is part of a premarket notification filed by Somas Medical Industries, Inc. with the FDA for Somas Human Spinal Fluid Control.
| Device ID | K840974 |
| 510k Number | K840974 |
| Device Name: | SOMAS HUMAN SPINAL FLUID CONTROL |
| Classification | Total Spinal-fluid, Antigen, Antiserum, Control |
| Applicant | SOMAS MEDICAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DFI |
| CFR Regulation Number | 866.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-06 |
| Decision Date | 1984-04-05 |