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FDA 510(k) Application Details - K060316
Device Classification Name
Pump, Infusion, Enteral
More FDA Info for this Device
510(K) Number
K060316
Device Name
Pump, Infusion, Enteral
Applicant
FRESENIUS KABI DEUTSCHLAND GMBH
DAIMLERSTRASSE 22
BAD HOMBURG D-61352 DE
Other 510(k) Applications for this Company
Contact
BARBARA BREUER-THAL
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
LZH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/08/2006
Decision Date
06/23/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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