The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Hph Junior High Performance Hemoconcentrator.
| Device ID | K050952 |
| 510k Number | K050952 |
| Device Name: | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Lynn Lueders |
| Correspondent | Lynn Lueders MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-15 |
| Decision Date | 2006-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30677964000868 | K050952 | 000 |