The following data is part of a premarket notification filed by Estracorporeal, Inc. with the FDA for Coil Dialysis, Models Dm-360 And Dm-360-.
| Device ID | K790382 |
| 510k Number | K790382 |
| Device Name: | COIL DIALYSIS, MODELS DM-360 AND DM-360- |
| Classification | Canister, Coil |
| Applicant | ESTRACORPOREAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKD |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-27 |
| Decision Date | 1979-05-02 |