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FDA 510(k) Application Details - K101385
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K101385
Device Name
Set, Administration, Intravascular
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
NANETTE HEDDEN
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2010
Decision Date
06/22/2010
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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