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FDA 510(k) Application Details - K011580
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K011580
Device Name
Set, Administration, Intravascular
Applicant
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA, MN 55391 US
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Contact
JOEL S DOUGLAS
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/2001
Decision Date
06/05/2001
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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