The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renatron Ii Dialyzer Reprocessing System Rs 8330.
Device ID | K904210 |
510k Number | K904210 |
Device Name: | RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 |
Classification | Dialyzer Reprocessing System |
Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
Contact | Leroy Fischbach |
Correspondent | Leroy Fischbach MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
Product Code | LIF |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-12 |
Decision Date | 1990-11-27 |