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FDA 510(k) Application Details - K072511
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K072511
Device Name
Set, I.V. Fluid Transfer
Applicant
MEDIMOP MEDICAL PROJECTS, LTD.
101 GORDON DRIVE
LIONVILLE, PA 19341 US
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Contact
ARI Y SOBEL
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
09/06/2007
Decision Date
12/13/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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