The following data is part of a premarket notification filed by Fresenius Kabi Deutschland Gmbh with the FDA for Compat Go Enteral Feeding Pump And Administration Sets.
Device ID | K060316 |
510k Number | K060316 |
Device Name: | COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS |
Classification | Pump, Infusion, Enteral |
Applicant | FRESENIUS KABI DEUTSCHLAND GMBH DAIMLERSTRASSE 22 Bad Homburg, DE D-61352 |
Contact | Barbara Breuer-thal |
Product Code | LZH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-02-08 |
Decision Date | 2006-06-23 |
Summary: | summary |