The following data is part of a premarket notification filed by Dr. Franz Kohler Chemie Gmbh with the FDA for Custodiol Htk Solution.
| Device ID | K020924 |
| 510k Number | K020924 |
| Device Name: | CUSTODIOL HTK SOLUTION |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | DR. FRANZ KOHLER CHEMIE GMBH 2305 GOLD MINE RD. Brookeville, MD 20833 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey DR. FRANZ KOHLER CHEMIE GMBH 2305 GOLD MINE RD. Brookeville, MD 20833 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-21 |
| Decision Date | 2003-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40331330610002 | K020924 | 000 |
| 04033133105003 | K020924 | 000 |
| 04033133250000 | K020924 | 000 |
| 04033133420007 | K020924 | 000 |
| 04033133610002 | K020924 | 000 |
| 40331330050006 | K020924 | 000 |
| 40331330105003 | K020924 | 000 |
| 40331330250000 | K020924 | 000 |
| 40331330420007 | K020924 | 000 |
| 04033133611016 | K020924 | 000 |