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FDA 510(k) Application Details - K041830
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K041830
Device Name
Syringe, Piston
Applicant
MEDTRONIC PERFUSION SYSTEMS
7611 NORTHLAND DR.
MINNEAPOLIS, MN 55038 US
Other 510(k) Applications for this Company
Contact
BRUCE BACKLUND
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/07/2004
Decision Date
09/29/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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