The following data is part of a premarket notification filed by Castle Co. with the FDA for Castle Model 3146 Gas Aerator.
| Device ID | K781484 |
| 510k Number | K781484 |
| Device Name: | CASTLE MODEL 3146 GAS AERATOR |
| Classification | Cabinet, Ethylene-oxide Gas Aerator |
| Applicant | CASTLE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLI |
| CFR Regulation Number | 880.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-28 |
| Decision Date | 1978-10-27 |