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FDA 510(k) Application Details - K110023
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K110023
Device Name
Set, I.V. Fluid Transfer
Applicant
CARMEL PHARMA AB.
AMINOGATAN 30
MOLNDAL S431 53 SE
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Contact
KJELL ANDREASSON
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
LHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/03/2011
Decision Date
04/12/2011
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
N
Expedited Review
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