CUSTODIOL
Set, Perfusion, Kidney, Disposable
DR. FRANZ KOHLER CHEMIE GMBH
The following data is part of a premarket notification filed by Dr. Franz Kohler Chemie Gmbh with the FDA for Custodiol.
Pre-market Notification Details
| Device ID | K043461 |
| 510k Number | K043461 |
| Device Name: | CUSTODIOL |
| 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 | 2004-12-15 |
| Decision Date | 2005-02-28 |
| Summary: | summary |
Trademark Results [CUSTODIOL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CUSTODIOL 75093836 2221916 Live/Registered |
Dr. Franz Kohler Chemie GmbH 1996-04-25 |
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