The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Hemocor Hph 700 Hemoconcentrator.
| Device ID | K983085 |
| 510k Number | K983085 |
| Device Name: | HEMOCOR HPH 700 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 | 1998-09-03 |
| Decision Date | 1998-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30677964011185 | K983085 | 000 |
| 30677964011178 | K983085 | 000 |