The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renaclear Dialyzer Cleaning System.
| Device ID | K991851 |
| 510k Number | K991851 |
| Device Name: | RENACLEAR 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 | 1999-06-01 |
| Decision Date | 1999-08-30 |
| Summary: | summary |