The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Hemocor Hph Mini Hemoconcentrator.
Device ID | K980859 |
510k Number | K980859 |
Device Name: | HEMOCOR HPH MINI HEMOCONCENTRATOR |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
Contact | Mark Murphy |
Correspondent | Mark Murphy 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 | 1998-03-05 |
Decision Date | 1998-05-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30677964011116 | K980859 | 000 |