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 | K192408 |
| 510k Number | K192408 |
| Device Name: | Custodiol HTK Solution |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | Dr. Franz Kohler Chemie GmbH Werner-von-Siemens-Strabe 14-28 Bensheim, DE 64625 |
| Contact | Clifton Czarnojon |
| Correspondent | Clifton Czarnojon Dr. Franz Kohler Chemie GmbH Werner-von-Siemens-Strabe 14-28 Bensheim, DE 64625 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-04-24 |