The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renaclean Sh Dialyzer Cleaning System.
| Device ID | K033505 |
| 510k Number | K033505 |
| Device Name: | RENACLEAN SH DIALYZER CLEANING SYSTEM |
| Classification | Dialyzer Reprocessing System |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Richard M Ormsbee |
| Correspondent | Richard M Ormsbee 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 | 2003-11-05 |
| Decision Date | 2004-04-27 |
| Summary: | summary |