The following data is part of a premarket notification filed by Dr. Franz Kohler Chemie Gmbh with the FDA for Custodiol.
Device ID | K032794 |
510k Number | K032794 |
Device Name: | CUSTODIOL |
Classification | System And Accessories, Isolated Heart, Transport And Preservation |
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 | MSB |
CFR Regulation Number | 876.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-08 |
Decision Date | 2004-04-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CUSTODIOL 75093836 2221916 Live/Registered |
Dr. Franz Kohler Chemie GmbH 1996-04-25 |