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FDA 510(k) Application Details - K032150
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K032150
Device Name
Set, Administration, Intravascular
Applicant
SARSTEDT, INC.
1025 ST. JAMES CHURCH RD.
PO BOX 468
NEWTON, NC 28658 US
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Contact
PETER RUMSWINKEL
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
07/14/2003
Decision Date
09/12/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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