The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Hemoconcentrator.
| Device ID | K123288 |
| 510k Number | K123288 |
| Device Name: | HEMOCONCENTRATOR |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Contact | Ingrid Richter |
| Correspondent | Ingrid Richter MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-22 |
| Decision Date | 2013-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058863039725 | K123288 | 000 |
| 04058863030913 | K123288 | 000 |