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 |