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FDA 510(k) Application Details - K031808
Device Classification Name
Tubing, Fluid Delivery
More FDA Info for this Device
510(K) Number
K031808
Device Name
Tubing, Fluid Delivery
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA, PA 15051 US
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Contact
ANDREW P ZELTWANGER
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPK
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More FDA Info for this Product Code
Date Received
06/12/2003
Decision Date
07/11/2003
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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