The following data is part of a premarket notification filed by Environmental Chemical Specialties with the FDA for Spinal Fluid Control(human).
| Device ID | K801854 |
| 510k Number | K801854 |
| Device Name: | SPINAL FLUID CONTROL(HUMAN) |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ENVIRONMENTAL CHEMICAL SPECIALTIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-04 |
| Decision Date | 1980-09-16 |