The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Hf Junior Hemofilter.
Device ID | K071298 |
510k Number | K071298 |
Device Name: | HF JUNIOR HEMOFILTER |
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 | 2007-05-09 |
Decision Date | 2007-08-08 |
Summary: | summary |