The following data is part of a premarket notification filed by Dr. Franz Kohler Chemie Gmbh with the FDA for Custodiol.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CUSTODIOL 75093836 2221916 Live/Registered |
Dr. Franz Kohler Chemie GmbH 1996-04-25 |