The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Hemocor Plus Hemoconcentrator.
Device ID | K872456 |
510k Number | K872456 |
Device Name: | HEMOCOR PLUS HEMOCONCENTRATOR |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
Contact | Leroy J Fischbach |
Correspondent | Leroy J Fischbach MINNTECH CORP. 14905 28TH AVE. N. 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 | 1987-06-23 |
Decision Date | 1987-09-15 |