The following data is part of a premarket notification filed by Steridoc Corp. with the FDA for Aseptic Fluid Transfer System.
| Device ID | K830811 |
| 510k Number | K830811 |
| Device Name: | ASEPTIC FLUID TRANSFER SYSTEM |
| Classification | Tubing, Dialysate (and Connector) |
| Applicant | STERIDOC CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | KQQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-15 |
| Decision Date | 1983-04-28 |