The following data is part of a premarket notification filed by Dialysis Systems, Inc. with the FDA for Nephrosol.
| Device ID | K822244 |
| 510k Number | K822244 |
| Device Name: | NEPHROSOL |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | DIALYSIS SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-27 |
| Decision Date | 1982-09-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEPHROSOL 75034514 2036840 Dead/Cancelled |
Minntech Corporation 1995-12-19 |
![]() NEPHROSOL 73734300 1520391 Dead/Cancelled |
MINNTECH CORPORATION 1988-06-09 |