The following data is part of a premarket notification filed by Computer Dialysis Systems, Inc. with the FDA for Forma-tag Usp Sodium Chloride Package 80gm & 120 G.
| Device ID | K850127 |
| 510k Number | K850127 |
| Device Name: | FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G |
| Classification | Dialyzer Reprocessing System |
| Applicant | COMPUTER DIALYSIS SYSTEMS, INC. Boulder, CO 80301 |
| Contact | Howard A Janneck |
| Correspondent | Howard A Janneck COMPUTER DIALYSIS SYSTEMS, INC. Boulder, CO 80301 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-03-20 |