The following data is part of a premarket notification filed by Spica, Inc. with the FDA for Oxygen/nitrous Oxide Outlet.
| Device ID | K780365 |
| 510k Number | K780365 |
| Device Name: | OXYGEN/NITROUS OXIDE OUTLET |
| Classification | Yoke Assembly, Medical Gas |
| Applicant | SPICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAM |
| CFR Regulation Number | 868.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-06 |
| Decision Date | 1978-03-30 |