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FDA 510(k) Application Details - K001368
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K001368
Device Name
Set, I.V. Fluid Transfer
Applicant
CARMEL PHARMA AB.
BOX 5352
GOTHENBURG 40228 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
05/01/2000
Decision Date
05/12/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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