CUSTODIOL
System, Perfusion, Kidney
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 | K992209 |
| 510k Number | K992209 |
| Device Name: | CUSTODIOL |
| Classification | System, Perfusion, Kidney |
| Applicant | DR. FRANZ KOHLER CHEMIE GMBH 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey DR. FRANZ KOHLER CHEMIE GMBH 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-30 |
| Decision Date | 1999-12-10 |
| 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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