The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Hemocor Hp Hemoconcentrator Series.
Device ID | K923139 |
510k Number | K923139 |
Device Name: | HEMOCOR HP HEMOCONCENTRATOR SERIES |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
Contact | Leroy J Fischbach |
Correspondent | Leroy J Fischbach 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 | 1992-06-29 |
Decision Date | 1994-02-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30677964011253 | K923139 | 000 |
00677964011245 | K923139 | 000 |
30677964011239 | K923139 | 000 |
30677964011222 | K923139 | 000 |
00677964011214 | K923139 | 000 |
30677964011208 | K923139 | 000 |