The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renaguard Dialysate Filter.
Device ID | K945136 |
510k Number | K945136 |
Device Name: | RENAGUARD DIALYSATE FILTER |
Classification | Subsystem, Water Purification |
Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
Contact | Leroy J Fischbach |
Correspondent | Leroy J Fischbach MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-20 |
Decision Date | 1995-02-28 |